Trial Outcomes & Findings for RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (NCT NCT00379769)

NCT ID: NCT00379769

Last Updated: 2017-03-23

Results Overview

The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4447 participants
• Primary outcome timeframe: Baseline through End of Study (up to 7.5 years)
• Results posted on: 2017-03-23

Participant Flow

The RECORD study ran from April 2001 through December 2008. Results are presented in the non-re-adjudicated outcome measures (OMs). An independent patient-level re-adjudication of mortality, non-fatal myocardial infarction, and non-fatal stroke began on January 2011 and ran through March 2012. The results are presented in the re-adjudicated OMs.

The RECORD observational follow-up (OFU) started at the end of the RECORD study and ran through December 2012. OFU was designed to collect cancer and bone fracture data. Participants were not provided with study medication in the OFU. Data are presented for the entire study (RECORD + OBF) and for OFU alone in the observational OMs.

Participant milestones

Measure	Combined MET/SU: Observational Follow-up Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.	RSG in Addition to Background MET Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	SU in Addition to Background MET Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG: Observational Follow-up Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Main Study STARTED	0	1117	1105	1103	1122	0
Main Study COMPLETED	0	939	906	896	892	0
Main Study NOT COMPLETED	0	178	199	207	230	0
Observational Follow-up STARTED	1250	0	0	0	0	1280
Observational Follow-up COMPLETED	1102	0	0	0	0	1131
Observational Follow-up NOT COMPLETED	148	0	0	0	0	149

Reasons for withdrawal

Measure	Combined MET/SU: Observational Follow-up Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.	RSG in Addition to Background MET Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	SU in Addition to Background MET Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG: Observational Follow-up Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Main Study Death	0	57	67	54	72	0
Main Study Adverse Event	0	5	8	10	11	0
Main Study Lost to Follow-up	0	29	29	25	26	0
Main Study Withdrawal by Subject	0	46	56	72	70	0
Main Study Moved to survival status follow-up only	0	27	25	32	36	0
Main Study Participant moved	0	3	2	3	3	0
Main Study Poor compliance	0	3	2	2	1	0
Main Study Prohibited glucose lowering medication	0	0	3	0	1	0
Main Study Site closed	0	4	4	4	8	0
Main Study Entry criteria violation	0	0	0	1	1	0
Main Study Participant did not take study drug	0	0	0	1	0	0
Main Study Physician Decision	0	2	2	1	1	0
Main Study Participant completed study at visit 27	0	1	0	0	0	0
Main Study Personal reasons	0	1	0	0	0	0
Main Study Risk of heart failure	0	0	1	0	0	0
Main Study Investigator refused to log temperature	0	0	0	1	0	0
Main Study Reason unspecified	0	0	0	1	0	0
Observational Follow-up Death	70	0	0	0	0	78
Observational Follow-up Adverse Event	0	0	0	0	0	1
Observational Follow-up Lost to Follow-up	27	0	0	0	0	25
Observational Follow-up Withdrawal by Subject	12	0	0	0	0	12
Observational Follow-up Entered into Another Clinical Trial	22	0	0	0	0	18
Observational Follow-up Physician Decision	8	0	0	0	0	8
Observational Follow-up Site Closed Early	7	0	0	0	0	6
Observational Follow-up Participant Moved	1	0	0	0	0	0
Observational Follow-up Unknown; Reason Not Provided	1	0	0	0	0	1

Baseline Characteristics

RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

Baseline characteristics by cohort

Measure	RSG in Addition to Background MET n=1117 Participants Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	SU in Addition to Background MET n=1105 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.	RSG in Addition to Background SU n=1103 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Total n=4447 Participants Total of all reporting groups
Age, Continuous	57.0 years STANDARD_DEVIATION 8.02 • n=5 Participants	57.2 years STANDARD_DEVIATION 8.14 • n=7 Participants	59.8 years STANDARD_DEVIATION 8.26 • n=5 Participants	59.7 years STANDARD_DEVIATION 8.23 • n=4 Participants	58.4 years STANDARD_DEVIATION 8.27 • n=21 Participants
Sex: Female, Male Female	516 Participants n=5 Participants	521 Participants n=7 Participants	562 Participants n=5 Participants	554 Participants n=4 Participants	2153 Participants n=21 Participants
Sex: Female, Male Male	601 Participants n=5 Participants	584 Participants n=7 Participants	541 Participants n=5 Participants	568 Participants n=4 Participants	2294 Participants n=21 Participants
Race/Ethnicity, Customized White	1105 participants n=5 Participants	1087 participants n=7 Participants	1095 participants n=5 Participants	1112 participants n=4 Participants	4399 participants n=21 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants	6 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants	14 participants n=21 Participants
Race/Ethnicity, Customized Oriental	4 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	7 participants n=4 Participants	18 participants n=21 Participants
Race/Ethnicity, Customized Aboriginal	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized African	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	4 participants n=21 Participants
Race/Ethnicity, Customized Egyptian	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Gipsy	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Indian	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Maori	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Middle East Hible	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Polynesian	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Sri Lankan	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized Tahitian	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events	323 participants	321 participants	—	—

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause	160 participants	139 participants	—	—

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions	188 participants	181 participants	—	—

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions	191 participants	186 participants	—	—

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as "unknown deaths," but were counted as CV deaths for the analysis of this endpoint.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions	96 participants	88 participants	—	—

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions	96 participants	88 participants	—	—

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions	60 participants	68 participants	—	—

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions	62 participants	72 participants	—	—

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions	63 participants	50 participants	—	—

PRIMARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions	64 participants	53 participants	—	—

SECONDARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With Cardiovascular Events and All-cause Deaths CV death, acute MI, stroke	165 participants	154 participants	—	—
Number of Participants With Cardiovascular Events and All-cause Deaths CV death, acute MI, stroke, unstable angina	184 participants	171 participants	—	—
Number of Participants With Cardiovascular Events and All-cause Deaths CV death, acute MI, stroke, unstable angina, CHF	206 participants	204 participants	—	—
Number of Participants With Cardiovascular Events and All-cause Deaths All-cause death,acuteMI,stroke,unstable angina,CHF	268 participants	251 participants	—	—
Number of Participants With Cardiovascular Events and All-cause Deaths Acute MI (fatal or non-fatal)	56 participants	64 participants	—	—
Number of Participants With Cardiovascular Events and All-cause Deaths Stroke (fatal or non-fatal)	63 participants	46 participants	—	—
Number of Participants With Cardiovascular Events and All-cause Deaths CHF (fatal or non-fatal)	29 participants	61 participants	—	—
Number of Participants With Cardiovascular Events and All-cause Deaths Death from CV causes	71 participants	60 participants	—	—
Number of Participants With Cardiovascular Events and All-cause Deaths Death (all cause) during CV follow-up	139 participants	111 participants	—	—
Number of Participants With Cardiovascular Events and All-cause Deaths Death (all-cause) including survival status	157 participants	136 participants	—	—

SECONDARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths CV deaths	71 Number of events	60 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Death due to acute MI	10 Number of events	7 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Death due to heart failure	2 Number of events	10 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Sudden death	12 Number of events	8 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Death due to acute vascular events	10 Number of events	1 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Other CV mortality	4 Number of events	6 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Death of presumed CV cause	33 Number of events	28 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Cardiovascular hospitalisation	490 Number of events	483 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Hospitalisation for acute MI	57 Number of events	66 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Hospitalisation for unstable angina	28 Number of events	28 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Hospitalisation for congestive heart failure	36 Number of events	69 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Hospitalisation for stroke	67 Number of events	51 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Hospitalisation for transient ischaemic attack	10 Number of events	10 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Hospitalisation for invasive CV procedure	116 Number of events	99 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Hospitalisation for amputation of extremities	23 Number of events	6 Number of events	—	—
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths Other CV hospitalisations	153 Number of events	154 Number of events	—	—

SECONDARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.

Outcome measures

Measure	Combined MET/SU n=1105 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1117 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1103 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum	154 partcipants	158 partcipants	163 partcipants	169 partcipants

SECONDARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With CV/Microvascular Events Participants with a CV/Microvascular event	385 participants	363 participants	—	—
Number of Participants With CV/Microvascular Events Participants with any microvascular event	78 participants	59 participants	—	—
Number of Participants With CV/Microvascular Events Participants with any eye event	52 participants	42 participants	—	—
Number of Participants With CV/Microvascular Events Participants with any foot event	28 participants	19 participants	—	—
Number of Participants With CV/Microvascular Events Participants with any renal event	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: Baseline through to end of randomised dual therapy

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.

Outcome measures

Measure	Combined MET/SU n=1105 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1117 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1103 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With Glycaemic Failure Events	451 participants	281 participants	365 participants	424 participants

SECONDARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.

Outcome measures

Measure	Combined MET/SU n=1105 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1117 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1103 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With Addition of Third Oral Agent/Switch to Insulin First Event - Insulin	176 participants	38 participants	49 participants	165 participants
Number of Participants With Addition of Third Oral Agent/Switch to Insulin Participants with an event	183 participants	295 participants	344 participants	171 participants
Number of Participants With Addition of Third Oral Agent/Switch to Insulin First Event - Triple Therapy	7 participants	257 participants	296 participants	6 participants

SECONDARY outcome

Timeframe: Baseline through End of Study (up to 7.5 years)

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The number of participants starting insulin at any time during the study was recorded.

Outcome measures

Measure	Combined MET/SU n=1105 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1117 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1103 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
The Number of Participants Starting Insulin at Any Time During the Study	276 participants	126 participants	168 participants	259 participants

SECONDARY outcome

Timeframe: Baseline and Month 60 of randomised dual therapy treatment period

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.

Outcome measures

Measure	Combined MET/SU n=1079 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1096 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1073 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1079 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Change From Baseline in HbA1c at Month 60	0.17 Percent Standard Error 0.042	-0.14 Percent Standard Error 0.035	-0.24 Percent Standard Error 0.039	-0.10 Percent Standard Error 0.039

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.

Outcome measures

Measure	Combined MET/SU n=1078 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1095 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1074 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1079 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60	-0.29 mmol/L (millimoles/Liter) Standard Error 0.090	-1.38 mmol/L (millimoles/Liter) Standard Error 0.073	-2.00 mmol/L (millimoles/Liter) Standard Error 0.085	-0.94 mmol/L (millimoles/Liter) Standard Error 0.094

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.

Outcome measures

Measure	Combined MET/SU n=982 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=931 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=882 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=940 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60 Insulin, Adjusted Change from Baseline	3.7 picamoles/liter (pmol/L) Standard Error 1.77	-18.6 picamoles/liter (pmol/L) Standard Error 1.01	-16.9 picamoles/liter (pmol/L) Standard Error 1.65	-12.1 picamoles/liter (pmol/L) Standard Error 1.91
Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60 Pro-insulin, Adjusted Change from Baseline	4.2 picamoles/liter (pmol/L) Standard Error 0.43	-2.4 picamoles/liter (pmol/L) Standard Error 0.26	-3.2 picamoles/liter (pmol/L) Standard Error 0.48	-3.0 picamoles/liter (pmol/L) Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)

Outcome measures

Measure	Combined MET/SU n=1105 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1117 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1103 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60 HbA1c Responders	208 participants	265 participants	235 participants	180 participants
Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60 FPG Responders	180 participants	300 participants	257 participants	154 participants

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

Outcome measures

Measure	Combined MET/SU n=977 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=926 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=878 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=933 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60 Beta cell function	19.28 percent change Interval 14.66 to 24.09	20.54 percent change Interval 16.52 to 24.7	32.35 percent change Interval 26.55 to 38.41	12.43 percent change Interval 7.42 to 17.67
Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60 Insulin sensitivity	-3.45 percent change Interval -7.21 to 0.47	42.57 percent change Interval 37.57 to 47.76	42.07 percent change Interval 36.39 to 47.98	23.90 percent change Interval 19.36 to 28.61

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

Outcome measures

Measure	Combined MET/SU n=1105 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1117 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1103 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60 Total cholesterol	-9.09 percent change Interval -10.33 to -7.84	-5.49 percent change Interval -6.99 to -3.96	-2.91 percent change Interval -4.62 to -1.17	-9.68 percent change Interval -11.03 to -8.31
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60 HDL-cholesterol	2.57 percent change Interval 1.46 to 3.68	9.95 percent change Interval 8.44 to 11.49	7.73 percent change Interval 6.18 to 9.3	6.14 percent change Interval 4.88 to 7.42
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60 LDL-cholesterol	-17.68 percent change Interval -19.7 to -15.61	-12.70 percent change Interval -15.03 to -10.3	-8.99 percent change Interval -11.42 to -6.49	-17.80 percent change Interval -19.93 to -15.61
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60 Triglycerides	-1.95 percent change Interval -4.73 to 0.91	-7.97 percent change Interval -10.72 to -5.15	-2.68 percent change Interval -5.69 to 0.43	-2.50 percent change Interval -5.21 to 0.28
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60 Free fatty acids	2.79 percent change Interval -0.23 to 5.91	-16.46 percent change Interval -19.13 to -13.71	-11.58 percent change Interval -14.65 to -8.41	4.47 percent change Interval 1.23 to 7.81

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

Outcome measures

Measure	Combined MET/SU n=1105 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1117 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1103 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60 Total Cholesterol: HDL Cholesterol Ratio	-11.33 percent change Interval -12.82 to -9.81	-14.20 percent change Interval -15.98 to -12.39	-9.93 percent change Interval -11.83 to -7.98	-15.01 percent change Interval -16.44 to -13.55
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60 LDL Cholesterol: HDL-Cholesterol Ratio	-20.04 percent change Interval -22.16 to -17.87	-20.89 percent change Interval -23.24 to -18.46	-15.85 percent change Interval -18.26 to -13.37	-22.53 percent change Interval -24.63 to -20.37

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

Outcome measures

Measure	Combined MET/SU n=1007 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=949 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=906 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=970 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60	-11.63 percent change Interval -13.1 to -10.14	-13.77 percent change Interval -15.45 to -12.05	-9.68 percent change Interval -11.55 to -7.77	-12.09 percent change Interval -13.67 to -10.47

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

Outcome measures

Measure	Combined MET/SU n=921 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=899 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=891 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=901 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60	15.17 percent change Interval 6.73 to 24.28	8.31 percent change Interval -0.7 to 18.14	-3.43 percent change Interval -11.91 to 5.87	11.91 percent change Interval 3.1 to 21.46

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.

Outcome measures

Measure	Combined MET/SU n=1079 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1096 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1073 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1079 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Change From Baseline in Body Weight at Month 60	-0.54 kilograms Standard Error 0.192	3.93 kilograms Standard Error 0.263	4.72 kilograms Standard Error 0.235	-2.16 kilograms Standard Error 0.179

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.

Outcome measures

Measure	Combined MET/SU n=1077 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1094 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1073 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1078 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60	-21.73 U/L (Units/Liter) Interval -23.9 to -19.5	-37.43 U/L (Units/Liter) Interval -39.22 to -35.59	-30.17 U/L (Units/Liter) Interval -31.98 to -28.31	-24.00 U/L (Units/Liter) Interval -26.21 to -21.73

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.

Outcome measures

Measure	Combined MET/SU n=1032 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=972 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=926 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=994 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Change From Baseline in Waist Circumference at Month 60	0.65 cm (centimeters) Standard Error 0.214	2.70 cm (centimeters) Standard Error 0.266	3.00 cm (centimeters) Standard Error 0.263	-0.60 cm (centimeters) Standard Error 0.215

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.

Outcome measures

Measure	Combined MET/SU n=1079 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1096 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=1074 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1079 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60 SBP	-2.2 mmHg (millimeters of mercury) Standard Error 0.52	-1.9 mmHg (millimeters of mercury) Standard Error 0.54	-2.3 mmHg (millimeters of mercury) Standard Error 0.52	-0.6 mmHg (millimeters of mercury) Standard Error 0.53
Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60 DBP	-3.4 mmHg (millimeters of mercury) Standard Error 0.29	-3.6 mmHg (millimeters of mercury) Standard Error 0.34	-3.6 mmHg (millimeters of mercury) Standard Error 0.31	-2.3 mmHg (millimeters of mercury) Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

Outcome measures

Measure	Combined MET/SU n=987 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=942 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=887 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=952 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60	-28.92 percent change Interval -33.71 to -23.79	-57.40 percent change Interval -60.41 to -54.15	-56.50 percent change Interval -61.56 to -55.21	-36.29 percent change Interval -41.03 to -31.17

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

Outcome measures

Measure	Combined MET/SU n=987 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=918 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=875 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=941 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60	5.74 percent change Interval 4.22 to 7.28	2.12 percent change Interval 0.54 to 3.72	-0.23 percent change Interval -1.79 to 1.35	3.14 percent change Interval 1.38 to 4.93

SECONDARY outcome

Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase

Population: Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication

The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

Outcome measures

Measure	Combined MET/SU n=991 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=931 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU n=882 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=939 Participants Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60	15.01 percent change Interval 9.77 to 20.5	-9.85 percent change Interval -14.42 to -5.02	-7.79 percent change Interval -12.61 to -2.71	-0.64 percent change Interval -5.82 to 4.83

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined All neoplasms/cancer (N/C) (benign/malignant)	215 participants	196 participants	—	—
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined Malignant (Mal.) N/C	195 participants	179 participants	—	—
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined Mal. N/C; excluding non-melanomatous skin cancers	186 participants	164 participants	—	—

SECONDARY outcome

Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Population: Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

Outcome measures

Measure	Combined MET/SU n=1250 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1280 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up All neoplasms/cancer (N/C) (benign/malignant)	51 participants	60 participants	—	—
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up Malignant (Mal.) N/C	51 participants	59 participants	—	—
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up Mal. N/C; excluding non-melanomatous skin cancers	46 participants	55 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Lung	15 participants	19 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Skin (non-melanomatous)	13 participants	19 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Skin (melanomatous)	4 participants	6 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Metastases	18 participants	12 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Breast	23 participants	12 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Head and neck	7 participants	4 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Neurologic	3 participants	3 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Endocrine	6 participants	3 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Not specified	1 participants	0 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Other	3 participants	0 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Any genitourinary	57 participants	57 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Prostate	22 participants	22 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Renal	9 participants	12 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Uterine	16 participants	11 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Bladder	5 participants	8 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Vaginal/vulvar	1 participants	1 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Ovarian	4 participants	5 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Any gastrointestinal	62 participants	48 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Colon/rectal cancer	30 participants	22 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Colon	21 participants	14 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Gastric	5 participants	13 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Pancreatic	16 participants	5 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Liver	5 participants	4 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Gall bladder/biliary	5 participants	4 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Gastrointestinal; not specified	1 participants	0 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined Any hematologic	6 participants	12 participants	—	—

SECONDARY outcome

Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Population: Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

Outcome measures

Measure	Combined MET/SU n=1250 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1280 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Any genitourinary	8 participants	18 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Prostate	1 participants	7 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Renal	2 participants	5 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Uterine	4 participants	4 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Bladder	0 participants	2 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Vaginal/vulvar	1 participants	0 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Ovarian	0 participants	0 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Any gastrointestinal	19 participants	17 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Colon/rectal cancer	11 participants	5 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Colon	7 participants	2 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Gastric	1 participants	5 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Pancreatic	3 participants	4 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Liver	2 participants	2 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Gall bladder/biliary	1 participants	1 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Gastrointestinal; not specified	1 participants	0 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Any hematologic	1 participants	6 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Lung	6 participants	6 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Skin (non-melanomatous)	5 participants	6 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Skin (melanomatous)	2 participants	3 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Metastases	6 participants	3 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Breast	7 participants	2 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Head and neck	1 participants	2 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Neurologic	1 participants	1 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Endocrine	1 participants	0 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Not specified	0 participants	0 participants	—	—
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up Other	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Any cancer-related death	72 participants	59 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Any gastrointestinal event	34 participants	25 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Pancreatic	12 participants	4 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Colon/rectal	11 participants	6 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Gastric	3 participants	7 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Liver	4 participants	4 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Gall bladder/biliary	3 participants	4 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Gastrointestinal event; not specified	1 participants	0 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Any genitourinary event	15 participants	6 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Renal	3 participants	2 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Uterine	5 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Prostate	2 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Bladder	3 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Ovarian	2 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Lung	11 participants	13 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Any hematologic event	0 participants	4 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Skin (melanoma)	0 participants	3 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Skin (non-melanomatous)	0 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Metastases	4 participants	2 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Breast	3 participants	2 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Head and neck	2 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Any neurologic event	2 participants	2 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Endocrine	0 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined Not specified	1 participants	0 participants	—	—

SECONDARY outcome

Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Population: Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

Outcome measures

Measure	Combined MET/SU n=1250 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1280 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Any cancer-related death	24 participants	25 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Any gastrointestinal event	14 participants	10 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Pancreatic	3 participants	3 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Colon/rectal	6 participants	2 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Gastric	1 participants	2 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Liver	2 participants	2 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Gall bladder/biliary	1 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Gastrointestinal event; not specified	1 participants	0 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Any genitourinary event	0 participants	2 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Renal	0 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Uterine	0 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Prostate	0 participants	0 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Bladder	0 participants	0 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Ovarian	0 participants	0 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Lung	5 participants	4 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Any hematologic event	0 participants	4 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Skin (melanoma)	0 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Skin (non-melanomatous)	0 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Metastases	1 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Breast	3 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Head and neck	0 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Any neurologic event	1 participants	1 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Endocrine	0 participants	0 participants	—	—
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up Not specified	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined Overall, n=2220, 2227	151 participants	238 participants	—	—
Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined Male, n=1142, 1152	60 participants	82 participants	—	—
Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined Female, n=1078, 1075	91 participants	156 participants	—	—

SECONDARY outcome

Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Population: Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

Outcome measures

Measure	Combined MET/SU n=1250 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1280 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up Overall, n=1280, 1250	37 participants	64 participants	—	—
Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up Male, n=665, 635	11 participants	25 participants	—	—
Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up Female, n=615, 615	26 participants	39 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined Any event	57 participants	81 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined Upper limb	17 participants	41 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined Distal lower limb	16 participants	24 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined Femur/hip	11 participants	15 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined Spinal	9 participants	7 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined Pelvic	3 participants	0 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined Other	4 participants	7 participants	—	—

SECONDARY outcome

Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Population: Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

Outcome measures

Measure	Combined MET/SU n=1250 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1280 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up Any event	21 participants	35 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up Upper limb	5 participants	17 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up Distal lower limb	8 participants	9 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up Femur/hip	4 participants	6 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up Spinal	3 participants	2 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up Pelvic	1 participants	0 participants	—	—
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up Other	1 participants	2 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Any event, overall; n=2220, 2227	151 participants	238 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Any event, male; n=1142, 1152	60 participants	82 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Any event, female; n=1078, 1075	91 participants	156 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Upper limb, any event, overall; n=2220, 2227	70 participants	116 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Upper limb, any event, male; n=1142, 1152	22 participants	32 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Upper limb, any event, female; n=1078, 1075	48 participants	84 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Distal lower limb, any event, overall; n=2220, 222	40 participants	88 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Distal lower limb, any event, male; n=1142, 1152	14 participants	31 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Distal lower limb, any event, female; n=1078, 1075	26 participants	57 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Femur/hip, any event, overall; n=2220, 2227	13 participants	16 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Femur/hip, any event, male; n=1142, 1152	1 participants	4 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Femur/hip, any event, female; n=1078, 1075	12 participants	12 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Spinal, any event, overall; n=2220, 2227	14 participants	18 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Spinal, any event, male; n=1142, 1152	9 participants	7 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Spinal, any event, female; n=1078, 1075	5 participants	11 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Pelvic, any event, overall; n=2220, 2227	5 participants	0 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Pelvic, any event, male; n=1142, 1152	4 participants	0 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Pelvic, any event, female; n=1078, 1075	1 participants	0 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Unclassified, any event, overall; n=2220, 2227	0 participants	1 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Unclassified, any event, male; n=1142, 1152	0 participants	1 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Unclassified, any event, female; n=1078, 1075	0 participants	0 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Other, any event, overall; n=2220, 2227	26 participants	31 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Other, any event, male; n=1142, 1152	16 participants	18 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined Other, any event, female; n=1078, 1075	10 participants	13 participants	—	—

SECONDARY outcome

Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Population: Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

Outcome measures

Measure	Combined MET/SU n=1250 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1280 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Any event, overall; n=1280, 1250	37 participants	64 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Any event, male; n=665, 635	11 participants	25 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Any event, female; n=615, 615	26 participants	39 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Upper limb, any event, overall; n=1280, 1250	15 participants	33 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Upper limb, any event, male; n=665, 635	3 participants	10 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Upper limb, any event, female; n=615, 615	12 participants	23 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Distal lower limb, any event, overall; n=1280,1250	13 participants	18 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Distal lower limb, any event, male; n=665, 635	4 participants	9 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Distal lower limb, any event, female; n=615, 615	9 participants	9 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Femur/hip, any event, overall; n=1280, 1250	5 participants	6 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Femur/hip, any event, male; n=665, 635	0 participants	1 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Femur/hip, any event, female; n=615, 615	5 participants	5 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Spinal, any event, overall; n=1280, 1250	5 participants	4 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Spinal, any event, male; n=665, 635	4 participants	1 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Spinal, any event, female; n=615, 615	1 participants	3 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Pelvic, any event, overall; n=1280, 1250	1 participants	0 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Pelvic, any event, male; n=665, 635	1 participants	0 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Pelvic, any event, female; n=615, 615	0 participants	0 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Unclassified, any event, overall; n=1280, 1250	0 participants	1 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Unclassified, any event, male; n=665, 635	0 participants	1 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Unclassified, any event, female; n=615, 615	0 participants	0 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Other, any event, overall; n=1280, 1250	1 participants	6 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Other, any event, male; n=665, 635	1 participants	4 participants	—	—
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up Other, any event, female; n=615, 615	0 participants	2 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Any event, overall, n=2220, 2227	31 participants	31 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Any event, male, n=1142, 1152	13 participants	10 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Any event, female, n=1078, 1075	18 participants	21 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Hip, overall, n=2220, 2227	7 participants	9 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Hip, male, n=1142, 1152	1 participants	0 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Hip, female, n=1078, 1075	6 participants	9 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Pelvis, overall, n=2220, 2227	5 participants	0 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Pelvis, male, n=1142, 1152	4 participants	0 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Pelvis, female, n=1078, 1075	1 participants	0 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Upper leg, overall, n=2220, 2227	6 participants	7 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Upper leg, male, n=1142, 1152	0 participants	4 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Upper leg, female, n=1078, 1075	6 participants	3 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Any vertebral event, overall, n=2220, 2227	13 participants	16 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Any vertebral event, male, n=1142, 1152	8 participants	6 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Any vertebral event, female, n=1078, 1075	5 participants	10 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Lumbar spine, overall, n=2220, 2227	4 participants	10 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Lumbar spine, male, n=1142, 1152	3 participants	5 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Lumbar spine, female, n=1078, 1075	1 participants	5 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Thoracic spine, overall, n=2220, 2227	8 participants	5 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Thoracic spine, male, n=1142, 1152	4 participants	1 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Thoracic spine, female, n=1078, 1075	4 participants	4 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Cervical spine, overall, n=2220, 2227	1 participants	1 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Cervical spine, male, n=1142, 1152	1 participants	0 participants	—	—
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined Cervical spine, female, n=1078, 1075	0 participants	1 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined Any H/UA/FF event, overall, n=2220, 2227	46 participants	86 participants	—	—
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined Any H/UA/FF event, male, n=1142, 1152	15 participants	28 participants	—	—
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined Any H/UA/FF event, female, n=1078, 1075	31 participants	58 participants	—	—
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined High morbidity fractures, overall, n=2220, 2227	1 participants	5 participants	—	—
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined High morbidity fractures, male, n=1142, 1152	0 participants	0 participants	—	—
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined High morbidity fractures, female, n=1078, 1075	1 participants	5 participants	—	—
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined Non-high morbidity fractures, overall, n=2220, 222	4 participants	15 participants	—	—
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined Non-high morbidity fractures, male, n=1142, 1152	3 participants	2 participants	—	—
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined Non-high morbidity fractures, female, n=1078, 1075	1 participants	13 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined Any event	151 participants	238 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined Non-traumatic event	55 participants	113 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined Traumatic event	77 participants	110 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined Pathologic	4 participants	1 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined Unknown	19 participants	20 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined Data unavailable	3 participants	9 participants	—	—

SECONDARY outcome

Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Population: Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."

Outcome measures

Measure	Combined MET/SU n=1250 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1280 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up Any event	37 participants	64 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up Non-traumatic event,	14 participants	36 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up Traumatic event	17 participants	24 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up Pathologic	2 participants	1 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up Unknown	4 participants	1 participants	—	—
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up Data unavailable	1 participants	3 participants	—	—

SECONDARY outcome

Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)

Population: ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."

Outcome measures

Measure	Combined MET/SU n=2227 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=2220 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined Number of bone fracture events	174 bone fracture events	299 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined Unknown	5 bone fracture events	7 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined Normal healing with standard management	142 bone fracture events	250 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined Complication	13 bone fracture events	14 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined Additional therapeutic measures required	9 bone fracture events	16 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined Data unavailable	5 bone fracture events	12 bone fracture events	—	—

SECONDARY outcome

Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Population: Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."

Outcome measures

Measure	Combined MET/SU n=1250 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1280 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up Number of bone fracture events	41 bone fracture events	70 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up Unknown	1 bone fracture events	1 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up Normal healing with standard management	33 bone fracture events	51 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up Complication	4 bone fracture events	7 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up Additional therapeutic measures required	2 bone fracture events	3 bone fracture events	—	—
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up Data unavailable	1 bone fracture events	8 bone fracture events	—	—

SECONDARY outcome

Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Population: Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).

The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

Outcome measures

Measure	Combined MET/SU n=1250 Participants Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG n=1280 Participants Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent	RSG in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Femoral neck fracture	2 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Lumbar vertebral fracture	2 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Metastases to bone	2 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Metastases to liver	2 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Bladder cancer	0 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Fall	0 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Metastases to central nervous system	0 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Rib fracture	0 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Squamous cell carcinoma	0 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Acute myocardial infarction	1 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Brain neoplasm	1 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Gastric neoplasm	1 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Metastases to lung	1 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Patella fracture	1 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Any event	76 participants	99 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Ankle fracture	3 participants	6 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Prostate cancer	1 participants	7 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Lung neoplasm malignant	4 participants	4 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Breast cancer	6 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Basal cell carcinoma	3 participants	4 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Pancreatic carcinoma	3 participants	4 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Colon cancer	6 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Humerus fracture	1 participants	5 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Upper limb fracture	1 participants	5 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Malignant melanoma	2 participants	3 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Uterine cancer	3 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Gastric cancer	0 participants	4 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Wrist fracture	0 participants	4 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Hip fracture	1 participants	3 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Radius fracture	1 participants	3 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Forearm fracture	2 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Hepatic neoplasm malignant	2 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Rectal cancer	2 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Renal cancer	2 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Foot fracture	3 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Renal cell carcinoma	0 participants	3 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Femur fracture	1 participants	2 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Death	2 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Abdominal pain	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Acute myeloid leukaemia	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Acute respiratory failure	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Anaemia	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Benign salivary gland neoplasm	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Biliary colic	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Biliary neoplasm	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Bone neoplasm malignant	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Bronchial carcinoma	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Cardiac failure acute	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Chest pain	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Chronic lymphocytic leukaemia	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Colon neoplasm	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Contusion	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Drowning	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Dysplasia	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Endometrial cancer stage I	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Leukaemia	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Lower limb fracture	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Lung squamous cell carcinoma stage unspecified	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Lymphoma	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Malignant neoplasm of pleura	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Metastases to skin	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Metastases to testicle	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Metastatic renal cell carcinoma	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Oesophageal carcinoma	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Osteoarthritis	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Pancreatic necrosis	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Rectal cancer stage II	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Spinal fracture	1 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up T-cell lymphoma	1 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Urinary tract infection	1 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Uterine leiomyosarcoma	0 participants	1 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Biliary cancer metastatic	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Cervix carcinoma	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Chronic obstructive pulmonary disease	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Comminuted fracture	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Craniocerebral injury	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Gastrointestinal neoplasm	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Hepatic lesion	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Joint dislocation	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Laryngeal cancer	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Lip neoplasm malignant stage unspecified	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Lung neoplasm	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Metastases to lymph nodes	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Metastasis	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Musculoskeletal chest pain	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Myocardial infarction	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Non-Hodgkin's lymphoma	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Pubis fracture	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Pulmonary embolism	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Rectal cancer recurrent	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Rectal neoplasm	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Skin cancer	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Skin ulcer	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Small cell lung cancer stage unspecified	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Sternal fracture	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Subdural haemorrhage	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Sudden death	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Thoracic vertebral fracture	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Thyroid cancer	1 participants	0 participants	—	—
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up Vulval cancer	1 participants	0 participants	—	—

Adverse Events

RSG in Addition to Background MET

Serious events: 424 serious events

Other events: 1117 other events

Deaths: 0 deaths

SU in Addition to Background MET

Serious events: 428 serious events

Other events: 1105 other events

Deaths: 0 deaths

RSG in Addition to Background SU

Serious events: 427 serious events

Other events: 1103 other events

Deaths: 0 deaths

MET in Addition to Background SU

Serious events: 431 serious events

Other events: 1122 other events

Deaths: 0 deaths

Combined RSG: Observational Follow-up

Serious events: 99 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined MET/SU: Observational Follow-up

Serious events: 76 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	RSG in Addition to Background MET n=1117 participants at risk Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	SU in Addition to Background MET n=1105 participants at risk Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.	RSG in Addition to Background SU n=1103 participants at risk Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 participants at risk Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG: Observational Follow-up n=1280 participants at risk Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.	Combined MET/SU: Observational Follow-up n=1250 participants at risk Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Infections and infestations Pneumonia Bacterial	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Post Procedural Sepsis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pyelonephritis Chronic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Nausea	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Catheter Sepsis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Conjunctivitis Viral	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Cystitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Enteritis Infectious	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Gastroenteritis Bacterial	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Reflux Oesophagitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Groin Abscess	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Hepatitis C	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Herpes Zoster Oticus	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Infective Myositis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Intestinal Gangrene	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Lobar Pneumonia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Lung Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Lyme Disease	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Mastoiditis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Meningitis Viral	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Small Intestinal Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Pancreatitis Chronic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Necrotising Fasciitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Otitis Media Acute	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pancreatic Abscess	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Peridiverticulitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Periumbilical Abscess	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Abdominal Adhesions	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pneumococcal Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Pancreatic Cyst	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Pancreatitis Necrotising	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Duodenal Fistula	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastroduodenal Ulcer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Pancreatitis Acute	0.54% 6/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Abdominal Wall Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Abscess	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Device Related Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Escherichia Sepsis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Extradural Abscess	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Furuncle	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Hepatitis Viral	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Infected Cyst	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pneumonia Legionella	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pyelocystitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Tracheobronchitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Urethritis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Arteriosclerotic Gangrene	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Blister Infected	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Carbuncle	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Colostomy Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Diabetic Gangrene	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Ear Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Gastroenteritis Salmonella	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Rectal haemorrhage	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Constipation	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Diarrhoea	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Helicobacter gastritis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Herpes Ophthalmic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Keratitis herpetic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Meningitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Peritoneal Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pyothorax	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Subcutaneous Abscess	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Tonsillitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Hypertensive Encephalopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Hypokinesia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Lumbar Radiculopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Metabolic Encephalopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Duodenal ulcer Haemorrhage	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Umbilical Hernia	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Crohn's Disease	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Haemorrhoids	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Nerve Compression	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Nerve Root Compression	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Parkinsonism	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Scrotal Abscess	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Sialoadenitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Staphylococcal Sepsis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Abdominal Pain	0.45% 5/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Respiratory Tract Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pulmonary Tuberculosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Hyperaesthesia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Intracranial Haematoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Abdominal Cavity	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.54% 6/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.31% 4/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.24% 3/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.53% 6/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.48% 6/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.48% 6/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Migraine	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Lung	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Multiple Sclerosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Radiculopathy	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Vascular Dementia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Vascular Encephalopathy	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Demyelination	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Haemorrhagic Stroke	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Hypoxic Encephalopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Ischaemic Cerebral Infarction	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Cancer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval Cancer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Transient Ischaemic Attack	0.98% 11/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.3% 14/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.00% 11/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.98% 11/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Syncope	0.45% 5/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Sciatica	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Carotid Artery Stenosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Diabetic Neuropathy	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Ischaemic stroke	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.62% 7/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Epilepsy	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Syncope Vasovagal	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Female	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Carpal Tunnel syndrome	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Headache	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Cerebral Haemorrhage	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.31% 4/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.24% 3/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Dementia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Facial Paresis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Global Amnesia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Hemiparesis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Liver	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.31% 4/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.32% 4/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Loss of Consciousness	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Cerebral Infarction	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder Cancer	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.31% 4/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.23% 3/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Neoplasm	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Cancer	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.24% 3/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Cognitive Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Vertebrobasilar Insufficiency	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Aphasia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Haemorrhage Intracranial	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasm Malignant	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Colitis Ulcerative	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Neoplasm	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.23% 3/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Neoplasm	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Duodenal ulcer	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Dyspepsia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Hemiplegia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic Adenoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.90% 10/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.81% 9/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.71% 8/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.55% 7/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Myocardial Infarction	2.2% 25/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	2.0% 22/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	2.6% 29/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	2.0% 23/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Coronary Artery Stenosis	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.72% 8/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.62% 7/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiac Failure	1.4% 16/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.2% 13/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.71% 8/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Coronary Artery Disease	0.81% 9/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.63% 7/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.1% 12/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Myocardial Ischaemia	0.63% 7/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.63% 7/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiac Failure Acute	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Arrythmia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Bradycardia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiac Failure Congestive	2.2% 25/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.6% 18/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	2.1% 23/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.2% 13/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Angina Pectoris	2.1% 23/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.6% 18/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	2.1% 23/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.7% 19/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Angina Unstable	1.4% 16/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.8% 20/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.9% 21/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.6% 18/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Atrial Fibrillation	1.8% 20/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.4% 15/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.2% 13/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.2% 14/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Acute Myocardial Infarction	1.1% 12/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.00% 11/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.7% 19/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Acute Coronary Syndrome	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiac Failure Chronic	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Arteriosclerosis Coronary Artery	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Tachycardia	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Atrioventricular Block Complete	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiomegaly	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiovascular disorder	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiac Arrest	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Aortic Valve Disease	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Sick Sinus Syndrome	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Atrial Flutter	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiac Disorder	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Silent Myocardial Infarction	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Mitral Valve Incompetence	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Atrial Tachycardia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Atrioventricular Block Second Degree	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cor pulmonale	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Tachyarrhythmia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Aortic Valve Stenosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Coronary Artery Occlusion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Extrasystoles	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Pericardial Effusion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Tachycardia Paroxysmal	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Atrioventricular Block	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Bradyarrhythmia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiac Fibrillation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiac Flutter	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Cardiomyopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Left Ventricular Failure	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Mitral Valve Disease	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Pericarditis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Right Ventricular Failure	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Sinus Bradycardia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Ventricular Arrhythmia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Ventricular Fibrillation	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Congestive Cardiomyopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Sinus Tachycardia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Left Ventricular Hypertrophy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Myocardial Fibrosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Supraventricular Extrasystoles	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Tricuspid Valve Incompetence	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pnuemonia	1.9% 21/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.4% 15/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.00% 11/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.1% 12/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Erysipelas	0.54% 6/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.63% 7/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Sepsis	0.54% 6/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Cellulitis	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Adams-Stokes Syndrome	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Cardiac disorders Hypertensive Cardiomyopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastric Polyps	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Bronchitis	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pyelonephritis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Hiatus Hernia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Urinary Tract Infection	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Lower Respiratory Tract Infection	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Bronchopnuemonia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Gangrene	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Diverticulitis	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Abdominal Abscess	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Gastroenteritis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Post Procedural Infection	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Inguinal hernia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Urosepsis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Localised Infection	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Postoperative Wound Infection	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Pancreatitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Diverticulum	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Dysphagia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastric Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Vomiting	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Abdominal Pain Upper	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Dental caries	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Anal Abscess	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Orchitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pyelonephritis Acute	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Sinusitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Abscess Intestinal	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Appendiceal Abscess	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Bacterial Infection	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Brochiectasis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Campylobacter Gastroenteritis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Diverticulum Intestinal	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Faeces Discoloured	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Cholecystitis Infective	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastric Dysplasia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Normal Pressure Hydrocephalus	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Encephalitis Viral	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Endocarditis Viral	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Tension Headache	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Herpes Zoster	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Paralysis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Paraparesis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Presyncope	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Reversible Ischaemic Neurological Deficit	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastric Ulcer	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastritis Haemorrhagic	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Ruptured Cerebral Aneurysm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1112 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Cerebral Ischaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1112 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Brain Oedema	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1112 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Cerebrovascular Insufficiency	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Melaena	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Cervicobrachial Syndrome	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Hypertonia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Neuralgia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Polyneuropathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Radiculitis lumbosacral	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Pancreatic Pseudocyst	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Peritoneal Disorder	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Carotid Arteriosclerosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Colonic Fistula	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Cerebral Arteriosclerosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Cerebrovascular Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Colonic Polyp	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Flatulence	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Ileus	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Convulsion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Encephalopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Facial Palsy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Proctalgia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Anal Fistula	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Ascites	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Mechanical Ileus	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Infective Exacercbatn of Chronic Obstructive Airways Disease	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Laryngitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Liver Abscess	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Mastitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Myocardiac Abscess	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Infective Thrombosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Joint Abscess	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Osteomyelitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pharyngitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Phlebitis Infective	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Retroperitoneal Abscess	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Viral Infection	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Wound Infection	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Staphylococcal Infection	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Toxoplasmosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Upper Respiratory Tract Infection	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Pelvic Infection	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Appendicitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Arthritis Bacterial	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Bone	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiomyolipoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Salivary Gland Neoplasm	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Lymphocytic Leukaemia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Carcinoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hairy Cell Leukaemia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastritis	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal Cavity Cancer	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Neoplasm	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Adenoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal Wall Neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenocortical Carcinoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell carcinoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial Carcinoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Stage III	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epiglottic Carcinoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Lymph Nodes	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Adenocarcinoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer Metastatic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Stage IV	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer Metastatic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Adenoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyosarcoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Central Nervous System	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Lung Neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip Neoplasm Malignant Stage Unspecified	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Peritoneum	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Malignant melanoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Prostate	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal Neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile Duct Cancer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hair Follicle Tumour Benign	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer Metastatic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Mesenchymoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Breast	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Spine	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Renal Cell Carcinoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Fibroma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular Neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue Neoplasm Malignant Stage Unspecified	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Cerebrovascular Accident	1.6% 18/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	2.3% 25/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.9% 21/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	2.1% 24/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastric Ulcer Haemorrhage	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Abdominal Hernia Obstructive	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastrointestinal Inflammation	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Haematochezia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Intestinal Fistula	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Splenic Artery Aneurysm	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Abdominal Hernia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Appendicitis Perforated	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Diverticular Perforation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Diverticulitis Intestinal Haemorrhagic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Duodenal Perforation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastric Ulcer Perforation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Peptic Ulcer Perforation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Intestinal Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Pancreatic necrosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Peritonitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Rectal Polyp	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Salivary Gland Calculus	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Duodenitis Haemorrhagic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Enterocele	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Enterocolitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Faecaloma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Haematemesis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Intestinal Polyp	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Oesophagitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Peptic Ulcer Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Ankle Fracture	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.47% 6/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.24% 3/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Road Traffic Accident	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Humerus Fracture	0.45% 5/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.39% 5/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Fall	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Radius Fracture	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.23% 3/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Rib Fracture	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Upper Limb Fracture	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.39% 5/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Hip Fracture	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.23% 3/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Post Procedural Complication	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Thermal Burn	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Head Injury	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Joint Dislocation	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Meniscus Lesion	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Concussion	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Drug Toxicity	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Excoriation	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Facial Bones Fracture	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Overdose	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Skin Laceration	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Incisional Hernia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Injury	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Joint Injury	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Post Procedural haemorrhage	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Tibia fracture	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Wound Dehiscence	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Device Failure	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Accidental Overdose	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Alcohol Poisoning	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Cardiac Valve Replacement Complication	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Cartilage Injury	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Clavicle Fracture	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Dislocation of Joint Prosthesis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Gun Shot Wound	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Laceration	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Limb Injury	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Lower Limb Fracture	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Lung Injury	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Multiple Fractures	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Near Drowning	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Post Procedural Fistula	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Postoperative Ileus	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Postoperative Wound Complication	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Skull Fracture	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Accident	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Acetabulum Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Anastomotic Leak	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Contusion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Hand Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications In-Stent Arterial Restenosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Multiple Injuries	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Muscle Rupture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Pelvic Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Stent Occlusion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Traumatic Brain Injury	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Wound	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.24% 3/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Brain Contusion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Subdural Haematoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Arthropod Sting	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Asbestosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Epiphyseal Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Eyeball Rupture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Intentional Overdose	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Joint Sprain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Open Wound	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Shunt Occlusion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Synovial Rupture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.31% 4/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Fibula Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Limb Crushing Injury	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Limb Traumatic Amputation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Operative Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Patella Fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Post Laminectomy Syndrome	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Post-Traumatic Pain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Postoperative Hernia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Traumatic Haematoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Hypertension	0.63% 7/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.90% 10/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.91% 10/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.89% 10/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Thrombosis	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Deep Vein Thrombosis	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Aortic Stenosis	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Intermittent Claudication	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Varicose Vein	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Aortic Aneurysm	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Essential Hypertension	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Hypovolaemic Shock	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Thrombophlebitis	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Femoral Artery Occlusion	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Hypertensive Crisis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Hypotension	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Shock	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Iliac Artery Stenosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Peripheral Ischaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Accelerated Hypertension	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Arteriosclerosis obliterans	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Artery Dissection	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Circulatory Collapse	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Diabetic Microangiopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Haematoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Orthostatic Hypotension	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Shock Haemorrhagic	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Aortic Aneurysm Rupture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Arterial Occlusive Disease	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Arterial Stenosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Arterial Stenosis Limb	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Cardiovascular Insufficiency	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Extremity Necrosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Femoral Arterial Stenosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Labile Hypertension	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Malignant Hypertension	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Peripheral Arterial Occlusive Disease	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Peripheral Vascular Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Thrombophlebitis Superficial	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Venous Insufficiency	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Venous Thrombosis Limb	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Arteriosclerosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Arterial Thrombosis Limb	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Angiopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Arterial Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Ischaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Lymphoedema	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Phlebitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Venous Thrombosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Vascular disorders Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.4% 16/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.1% 12/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.2% 13/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.1% 12/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Back Pain	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.53% 6/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Myalgia	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Bursitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Arthritis	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Dupuytren's Contracture	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Diabetic Amyotrophy	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Gouty Arthritis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Senile Osteoporosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Tendonitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Foot Deformity	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Rheumatic Fever	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Compartment Syndrome	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Polymyalgia Rheumatica	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Groin Pain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Mobility Decreased	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Psoriatic Arthropathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.54% 6/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.81% 9/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Asthma	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.72% 8/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Bronchitis Chronic	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Nasal Polyps	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Alveolitis Fibrosing	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Respiratory Acidosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Lung Consolidation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Nasal Turbinate Hypertrophy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Tracheal Stenosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Dysnoea Paroxysmal Nocturnal	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Nocturnal Dyspnoea	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Respiratory Alkalosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Non-Cardiac Chest Pain	1.3% 14/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.1% 12/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Death	0.45% 5/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.53% 6/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Pyrexia	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Sudden Death	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Inflammation	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Multi-Organ Failure	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Sudden Cardiac Death	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Chest pain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Gait Disturbance	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Hernia Obstructive	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Chest Discomfort	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders General Physical Health Deterioration	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Pain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Drowning	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Oedema	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Oedema Peripheral	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Tenderness	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Brain Death	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Cholelithiasis	1.3% 15/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.2% 13/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.82% 9/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.89% 10/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Cholecystitis	0.45% 5/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Cholecystitis Acute	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Liver Disorder	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Biliary Colic	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Cholangitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Cholecystitis Chronic	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Hepatic Failure	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Bile Duct Obstruction	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Bile Duct Stone	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Jaundice	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Jaundice Cholestatic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Hepatic Cirrhosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Gallbladder Polyp	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Cholestasis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Hepatitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Hepatitis Alcoholic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Post Cholecystectomy Syndrome	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Hypoglycaemia	0.45% 5/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.91% 10/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Hyperglycaemia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.81% 9/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.80% 9/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Diabetes Mellitus	0.36% 4/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.91% 10/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.5% 17/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.89% 10/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Dehydration	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Diabetic Foot	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Acidosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Metabolic Acidosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Anorexia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Haemochromatosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Obesity	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Cachexia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Diabetic Complication	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Gout	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Hypeonatraemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Podagra	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Increased Insulin Requirement	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Nephrolithiasis	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.72% 8/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Renal Failure Acute	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.72% 8/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Renal Failure	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Renal Colic	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Urinary Retention	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Calculus Ureteric	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Calculus Urinary	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Haematuria	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Cystitis Noninfective	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Acute Prerenal Failure	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Hydronephrosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Urethral Fistula	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Urinary Bladder Haemorrhage	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Bladder Perforation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Diabetic Nephropathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Urinary Tract Obstruction	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Urethral Stenosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Renal Cyst	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Albuminuria	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Calculus Bladder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Renal Pain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Urinary Incontinence	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Urinary Tract Inflammation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Azotaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Calculus Urethral	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Ketonuria	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Renal Embolism	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Renal and urinary disorders Urine Flow Decreased	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Uterine Prolapse	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Cystocele	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Rectocele	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Breast Disorder	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Cervical Polyp	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Endometrial Hypertrophy	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Menometrorrhagia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Ovarian Cyst	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Peyronie's Disease	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Prostatitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Testicular Pain	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Vaginal Prolapse	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Fibrocystic Breast Disease	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Vaginal Cyst	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Vulvovaginal Dryness	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Epididymitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Uterine Polyp	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Orchitis Noninfective	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Pelvic Peritoneal Adhesions	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Postmenopausal Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Prostatic Obstruction	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Vulvovaginal Pruritus	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Prostatism	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Vaginal Polyp	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Reproductive system and breast disorders Vulval Leukoplakia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Cataract	0.45% 5/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	1.1% 12/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.80% 9/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Retinal Detachment	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Angle Closure Glaucoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Maculopathy	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Glaucoma	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Cataract Nuclear	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Inflammation of Lacrimal Passage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Retinal Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Vitreous Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Diabetic Retinopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Eye Haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Dacryostenosis Acquired	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Exudative Retinopathy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Macular Degeneration	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Optic Atrophy	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Keratitis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Lens Dislocation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Retinal Vein Thrombosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Blood and lymphatic system disorders Anaemia	0.72% 8/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Blood and lymphatic system disorders Hypocoagulable State	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Blood and lymphatic system disorders Thrombocytopenia	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Blood and lymphatic system disorders Idiopathic Thrombocytopenic Purpura	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Blood and lymphatic system disorders Autoimmune Thrombocytopenia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Blood and lymphatic system disorders Haemolytic Anaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Depression	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Confusional State	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Alcohol Abuse	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Suicide Attempt	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Mania	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Bipolar Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Completed Suicide	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Dysthymic Disorder	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Ear and labyrinth disorders Vertigo	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.54% 6/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.45% 5/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Ear and labyrinth disorders Hypoacusis	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Ear and labyrinth disorders Otosclerosis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Ear and labyrinth disorders Sudden Hearing Loss	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Ear and labyrinth disorders Tinnitus	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Ear and labyrinth disorders Vestibular Disorder	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Ear and labyrinth disorders Vestibular Neuronitis	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Ear and labyrinth disorders Vertigo Positional	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Endocrine disorders Goitre	0.18% 2/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Endocrine disorders Hyperthyroidism	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Endocrine disorders Hyperparathyroidism	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Endocrine disorders Hyperparathyroidism Primary	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Endocrine disorders Parathyroid Gland Enlargement	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Endocrine disorders Toxic Nodular Goitre	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Endocrine disorders Adrenal Mass	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Endocrine disorders Basedow's Disease	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Angioedema	0.27% 3/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Drug Eruption	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Lichen Planus	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Skin and subcutaneous tissue disorders Pityriasis Rubra Pilaris	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Investigations Blood glucose Increased	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.18% 2/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.36% 4/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Investigations Electrocardiogram T Wave Abnormal	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Investigations Blood Pressure Increased	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Investigations Liver Function Test Abnormal	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Investigations Weight Decreased	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Investigations Blood Creatinine Increased	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Investigations Blood Urea Increased	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Investigations Haemoglobin Decreased	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Investigations Chest X-ray Abnormal	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Immune system disorders Drug Hypersensitivity	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Immune system disorders Hypersensitivity	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.27% 3/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Immune system disorders Anaphylactic Reaction	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Congenital, familial and genetic disorders Corneal Dystrophy	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Congenital, familial and genetic disorders Gastrointestinal Angiodysplasia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.09% 1/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Otitis media	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Splenic abscess	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Disorientation	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Anxiety	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Biliary neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm malignant	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of pleura	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to skin	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to testicle	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage II	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Biliary cancer metastatic	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Hepatobiliary disorders Hepatic lesion	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer recurrent	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.16% 2/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.09% 1/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Dysplasia	0.00% 0/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.08% 1/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.

Other adverse events

Measure	RSG in Addition to Background MET n=1117 participants at risk Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	SU in Addition to Background MET n=1105 participants at risk Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.	RSG in Addition to Background SU n=1103 participants at risk Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	MET in Addition to Background SU n=1122 participants at risk Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.	Combined RSG: Observational Follow-up n=1280 participants at risk Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.	Combined MET/SU: Observational Follow-up n=1250 participants at risk Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
Vascular disorders Hypertension	30.9% 345/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	33.7% 372/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	27.4% 302/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	28.4% 319/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Nasopharyngitis	19.3% 216/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	18.3% 202/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	11.0% 121/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	10.9% 122/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Hyperlipidaemia	21.1% 236/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	13.0% 144/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	17.5% 193/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	10.7% 120/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Dyslipidaemia	6.5% 73/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.1% 45/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	7.3% 81/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.1% 57/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Back Pain	13.7% 153/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	12.9% 143/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	8.6% 95/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	9.4% 105/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Cataract	4.6% 51/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	6.0% 66/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.1% 56/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	6.0% 67/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Bronchitis	12.4% 139/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	11.6% 128/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	12.3% 136/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	10.9% 122/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Arthralgia	10.7% 119/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	11.4% 126/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	8.9% 98/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	6.2% 70/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Hypoglycaemia	4.6% 51/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	17.2% 190/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	14.7% 162/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	12.8% 144/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Influenza	9.8% 110/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	11.7% 129/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	9.6% 106/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	7.8% 88/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Hypercholesterolaemia	10.8% 121/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	7.1% 78/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	14.1% 155/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.7% 64/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
General disorders Oedema peripheral	12.9% 144/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.3% 47/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	12.1% 133/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.7% 41/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Gastrointestinal disorders Diarrhoea	5.4% 60/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	7.3% 81/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.0% 44/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	12.0% 135/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Respiratory, thoracic and mediastinal disorders Cough	7.3% 81/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	7.1% 79/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.5% 61/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.5% 51/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Blood and lymphatic system disorders Anaemia	9.4% 105/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.1% 45/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.0% 55/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.4% 38/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Psychiatric disorders Depression	6.0% 67/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.3% 47/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.1% 34/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.1% 35/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Metabolism and nutrition disorders Diabetes mellitus	4.6% 51/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	8.8% 97/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.4% 49/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	6.1% 68/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Dizziness	5.4% 60/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.4% 38/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.2% 46/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.7% 42/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Diabetic neuropathy	4.8% 54/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.8% 53/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	7.9% 87/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.6% 63/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Eye disorders Diabetic retinopathy	3.9% 44/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.8% 53/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.6% 51/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.4% 61/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Viral infection	4.8% 54/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.1% 45/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.1% 56/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.6% 40/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Urinary tract infection	5.9% 66/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	6.0% 66/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.3% 59/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.4% 49/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Infections and infestations Upper respiratory tract infection	6.5% 73/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.0% 55/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.1% 34/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.1% 35/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Nervous system disorders Headache	5.9% 66/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.5% 61/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.3% 58/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.2% 47/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 59/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	6.1% 67/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.9% 54/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	3.7% 42/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 102/1117 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	7.4% 82/1105 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	5.6% 62/1103 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	4.5% 50/1122 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1280 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.	0.00% 0/1250 • In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years). The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.

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