Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old (NCT NCT03199053)

NCT ID: NCT03199053

Last Updated: 2024-06-21

Results Overview

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on multiple imputation washout (MI-WO) within each arm using the data from placebo participants with Week 26 data.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 256 participants
• Primary outcome timeframe: Baseline and Week 26
• Results posted on: 2024-06-21

Participant Flow

A total of 245 patients were randomised from 94 sites in 21 countries. Participants were initially randomised in a 1:1:1 ratio to receive dapagliflozin 5 mg, saxagliptin 2.5 mg, or placebo.

An initial 26-week short-term (ST) period was followed by a 26-week long-term (LT) safety extension period. The study drug was discontinued at Week 52, after which participants continued in the Non-treatment Follow-up Period until Week 104. Of the 256 participants enrolled, 11 were excluded from analysis due to GCP considerations at the site they originated from (see limitations and caveats for further details).

Participant milestones

Measure	Dapagliflozin Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 glycated haemoglobin (HbA1c) values \< 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.	Saxagliptin Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.	Placebo Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation. After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
ST Period STARTED	81	88	76
ST Period Week 14 no Uptitration Randomisation	39	36	0
ST Period Week 14 Uptitration Randomisation	42	52	0
ST Period COMPLETED	76	83	68
ST Period NOT COMPLETED	5	5	8
LT Period STARTED	76	83	68
LT Period Randomised Withdrawal Patients Data Set	13	25	8
LT Period Excluded From Randomised Withdrawal Patients Data Set	68	63	68
LT Period Randomised to Continue Metformin	6	12	2
LT Period Randomised Metformin Withdrawal	7	13	6
LT Period COMPLETED	75	79	61
LT Period NOT COMPLETED	1	4	7
Non-treatment Follow-up Period STARTED	74	77	59
Non-treatment Follow-up Period COMPLETED	67	68	52
Non-treatment Follow-up Period NOT COMPLETED	7	9	7

Reasons for withdrawal

Measure	Dapagliflozin Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 glycated haemoglobin (HbA1c) values \< 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.	Saxagliptin Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.	Placebo Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation. After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
ST Period Withdrawal by Subject	2	4	6
ST Period Withdrawal by parent/guardian	1	1	1
ST Period Lost to Follow-up	2	0	1
LT Period Withdrawal by Subject	1	3	3
LT Period Withdrawal by parent/guardian	0	0	1
LT Period Lost to Follow-up	0	1	1
LT Period Miscellaneous	0	0	2
Non-treatment Follow-up Period Withdrawal by Subject	2	1	0
Non-treatment Follow-up Period Withdrawal by parent/guardian	2	3	2
Non-treatment Follow-up Period Lost to Follow-up	3	4	5
Non-treatment Follow-up Period Miscellaneous	0	1	0

Baseline Characteristics

Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old

Baseline characteristics by cohort

Measure	Dapagliflozin n=81 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 glycated haemoglobin (HbA1c) values \< 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.	Saxagliptin n=88 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.	Placebo n=76 Participants Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation. After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.	Total n=245 Participants Total of all reporting groups
Age, Continuous	14.4 years STANDARD_DEVIATION 2.00 • n=5 Participants	14.5 years STANDARD_DEVIATION 1.75 • n=7 Participants	14.7 years STANDARD_DEVIATION 1.64 • n=5 Participants	14.5 years STANDARD_DEVIATION 1.80 • n=4 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	53 Participants n=7 Participants	44 Participants n=5 Participants	146 Participants n=4 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	35 Participants n=7 Participants	32 Participants n=5 Participants	99 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=5 Participants	43 Participants n=7 Participants	34 Participants n=5 Participants	122 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	45 Participants n=7 Participants	42 Participants n=5 Participants	123 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White	42 Participants n=5 Participants	50 Participants n=7 Participants	32 Participants n=5 Participants	124 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Asian	18 Participants n=5 Participants	23 Participants n=7 Participants	24 Participants n=5 Participants	65 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	11 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	30 Participants n=4 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Mean Baseline HbA1c	8.22 Percentage HbA1c STANDARD_DEVIATION 1.459 • n=5 Participants	8.02 Percentage HbA1c STANDARD_DEVIATION 1.431 • n=7 Participants	7.96 Percentage HbA1c STANDARD_DEVIATION 1.629 • n=5 Participants	8.07 Percentage HbA1c STANDARD_DEVIATION 1.502 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on multiple imputation washout (MI-WO) within each arm using the data from placebo participants with Week 26 data.

Outcome measures

Measure	Saxagliptin 2.5 mg n=70 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=75 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26	0.41 Percentage HbA1c Standard Error 0.218	-0.62 Percentage HbA1c Standard Error 0.218	—	—

PRIMARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Outcome measures

Measure	Saxagliptin 2.5 mg n=70 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=82 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26	0.50 Percentage HbA1c Standard Error 0.202	0.06 Percentage HbA1c Standard Error 0.198	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and weighted as pre-specified in the statistical analysis plan.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=70 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=54 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26	0.43 Percentage HbA1c Standard Error 0.207	-0.42 Percentage HbA1c Standard Error 0.214	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=70 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=58 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26	0.47 Percentage HbA1c Standard Error 0.200	-0.04 Percentage HbA1c Standard Error 0.190	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and weighted as pre-specified in the statistical analysis plan.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=70 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=56 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26	0.40 Percentage HbA1c Standard Error 0.205	-0.79 Percentage HbA1c Standard Error 0.202	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=70 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=57 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26	0.47 Percentage HbA1c Standard Error 0.194	0.07 Percentage HbA1c Standard Error 0.188	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Outcome measures

Measure	Saxagliptin 2.5 mg n=68 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=75 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	0.51 mmol/L Standard Error 0.384	-0.57 mmol/L Standard Error 0.374	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Outcome measures

Measure	Saxagliptin 2.5 mg n=68 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=80 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in FPG at Week 26	0.19 mmol/L Standard Error 0.428	0.08 mmol/L Standard Error 0.413	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and weighted as pre-specified in the statistical analysis plan.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=68 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=54 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26	0.70 mmol/L Standard Error 0.369	-0.34 mmol/L Standard Error 0.365	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=68 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=57 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26	0.73 mmol/L Standard Error 0.359	0.18 mmol/L Standard Error 0.331	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and weighted as pre-specified in the statistical analysis plan.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=68 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=56 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26	0.56 mmol/L Standard Error 0.363	-0.56 mmol/L Standard Error 0.347	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=68 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=55 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26	0.34 mmol/L Standard Error 0.446	0.63 mmol/L Standard Error 0.424	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with Baseline HbA1c \>= 7% and available data only.

A logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Outcome measures

Measure	Saxagliptin 2.5 mg n=61 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=64 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg n=50 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26	21.3 Percentage of participants	26.6 Percentage of participants	10.0 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with Baseline HbA1c \>= 7% and available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.

A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=41 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=44 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg n=50 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Low-dose/High-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26	24.4 Percentage of participants	27.3 Percentage of participants	10.0 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with Baseline HbA1c \>= 7% and available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.

A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.

Outcome measures

Measure	Saxagliptin 2.5 mg n=38 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=45 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg n=50 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Low-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26	28.9 Percentage of participants	35.6 Percentage of participants	10.0 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Uptitration Randomised Participants Data Set: consisted of the subset of randomised participants who were up-titration randomised because their HbA1c is greater than or equal to 7% at Week 12 (regardless of rescue medication initiation). Includes participants with available data only.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Outcome measures

Measure	Saxagliptin 2.5 mg n=21 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=19 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg n=25 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg n=24 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in HbA1c at Week 26	-0.71 Percentage HbA1c Standard Error 0.384	-0.74 Percentage HbA1c Standard Error 0.368	-0.16 Percentage HbA1c Standard Error 0.361	0.07 Percentage HbA1c Standard Error 0.372

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Uptitration Randomised Participants Data Set: consisted of the subset of randomised participants who were up-titration randomised because their HbA1c is greater than or equal to 7% at Week 12 (regardless of rescue medication initiation). Includes participants with available data only.

Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Outcome measures

Measure	Saxagliptin 2.5 mg n=21 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=19 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg n=25 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg n=23 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in FPG at Week 26	-0.98 mmol/L Standard Error 0.683	-1.62 mmol/L Standard Error 0.689	-2.38 mmol/L Standard Error 0.734	-0.56 mmol/L Standard Error 0.763

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Uptitration Randomised Participants Data Set: consisted of the subset of randomised participants who were up-titration randomised because their HbA1c is greater than or equal to 7% at Week 12 (regardless of rescue medication initiation). Includes participants with available data only.

A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Outcome measures

Measure	Saxagliptin 2.5 mg n=20 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=19 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Dapagliflozin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26	25.0 Percentage of participants	5.3 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Uptitration Randomised Participants Data Set: consisted of the subset of randomised participants who were up-titration randomised because their HbA1c is greater than or equal to 7% at Week 12 (regardless of rescue medication initiation). Includes participants with available data only.

A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.

Outcome measures

Measure	Saxagliptin 2.5 mg n=20 Participants Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Dapagliflozin 10 mg n=23 Participants Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.	Saxagliptin 2.5 mg Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose). After completion of the ST treatment period, participants could enter the LT treatment period.
Saxagliptin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26	15.0 Percentage of participants	8.7 Percentage of participants	—	—

Adverse Events

Weeks 1 to 14: Dapagliflozin 5 mg

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Weeks 14 to 26: Dapagliflozin 5 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Weeks 14 to 26: Dapagliflozin 10 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Weeks 26 to 56: Dapagliflozin 5 mg

Serious events: 5 serious events

Other events: 26 other events

Deaths: 0 deaths

Weeks 26 to 56: Dapagliflozin 10 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Weeks 32 or 40 to 56: Dapagliflozin 10 mg + Metformin Withdrawal

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Weeks 1 to 14: Saxagliptin 2.5 mg

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Weeks 14 to 26: Saxagliptin 2.5 mg

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Weeks 14 to 26: Saxagliptin 5 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Weeks 26 to 56: Saxagliptin 2.5 mg

Serious events: 3 serious events

Other events: 23 other events

Deaths: 0 deaths

Weeks 26 to 56: Saxagliptin 5 mg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Weeks 32 or 40 to 56: Saxagliptin 5 mg + Metformin Withdrawal

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Weeks 1 to 14: Placebo

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Weeks 14 to 26: Placebo

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Weeks 26 to 32 or 40: Placebo

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

Weeks 32 or 40 to 56: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Weeks 32 or 40 to 56: Placebo to Dapagliflozin 10 mg + Metformin Withdrawal

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Weeks 32 or 40 to 56: Placebo to Saxagliptin 5 mg + Metformin Withdrawal

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Week 56 to 104: Non-treatment Follow-up Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Weeks 1 to 14: Dapagliflozin 5 mg n=81 participants at risk Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose).	Weeks 14 to 26: Dapagliflozin 5 mg n=55 participants at risk At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).	Weeks 14 to 26: Dapagliflozin 10 mg n=21 participants at risk At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).	Weeks 26 to 56: Dapagliflozin 5 mg n=55 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.	Weeks 26 to 56: Dapagliflozin 10 mg n=21 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.	Weeks 32 or 40 to 56: Dapagliflozin 10 mg + Metformin Withdrawal n=7 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment.	Weeks 1 to 14: Saxagliptin 2.5 mg n=88 participants at risk Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose).	Weeks 14 to 26: Saxagliptin 2.5 mg n=61 participants at risk At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).	Weeks 14 to 26: Saxagliptin 5 mg n=26 participants at risk At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).	Weeks 26 to 56: Saxagliptin 2.5 mg n=61 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.	Weeks 26 to 56: Saxagliptin 5 mg n=26 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.	Weeks 32 or 40 to 56: Saxagliptin 5 mg + Metformin Withdrawal n=13 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment.	Weeks 1 to 14: Placebo n=76 participants at risk Participants were randomised to receive placebo administered orally once daily.	Weeks 14 to 26: Placebo n=70 participants at risk At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.	Weeks 26 to 32 or 40: Placebo n=70 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.	Weeks 32 or 40 to 56: Placebo n=53 participants at risk Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.	Weeks 32 or 40 to 56: Placebo to Dapagliflozin 10 mg + Metformin Withdrawal n=3 participants at risk At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.	Weeks 32 or 40 to 56: Placebo to Saxagliptin 5 mg + Metformin Withdrawal n=3 participants at risk At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.	Week 56 to 104: Non-treatment Follow-up Period n=210 participants at risk Safety monitoring continued in the Non-treatment Follow-up Period quarterly between the Week 56 and Week 104 visits.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Glycosylated haemoglobin increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Transaminases increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Euglycaemic diabetic ketoacidosis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.3% 2/61 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Nervous system disorders Presyncope	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Haematuria	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Reproductive system and breast disorders Ovarian cyst	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Gastritis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Appendicitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Covid-19	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Gastroenteritis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Urinary tract infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.

Other adverse events

Measure	Weeks 1 to 14: Dapagliflozin 5 mg n=81 participants at risk Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose).	Weeks 14 to 26: Dapagliflozin 5 mg n=55 participants at risk At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).	Weeks 14 to 26: Dapagliflozin 10 mg n=21 participants at risk At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).	Weeks 26 to 56: Dapagliflozin 5 mg n=55 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.	Weeks 26 to 56: Dapagliflozin 10 mg n=21 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.	Weeks 32 or 40 to 56: Dapagliflozin 10 mg + Metformin Withdrawal n=7 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment.	Weeks 1 to 14: Saxagliptin 2.5 mg n=88 participants at risk Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose).	Weeks 14 to 26: Saxagliptin 2.5 mg n=61 participants at risk At Week 14, participants with Week 12 HbA1c values \< 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).	Weeks 14 to 26: Saxagliptin 5 mg n=26 participants at risk At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).	Weeks 26 to 56: Saxagliptin 2.5 mg n=61 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.	Weeks 26 to 56: Saxagliptin 5 mg n=26 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.	Weeks 32 or 40 to 56: Saxagliptin 5 mg + Metformin Withdrawal n=13 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. A subset of eligible participants (on background treatment with metformin only and who had HbA1c \< 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment.	Weeks 1 to 14: Placebo n=76 participants at risk Participants were randomised to receive placebo administered orally once daily.	Weeks 14 to 26: Placebo n=70 participants at risk At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.	Weeks 26 to 32 or 40: Placebo n=70 participants at risk After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.	Weeks 32 or 40 to 56: Placebo n=53 participants at risk Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation. At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.	Weeks 32 or 40 to 56: Placebo to Dapagliflozin 10 mg + Metformin Withdrawal n=3 participants at risk At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.	Weeks 32 or 40 to 56: Placebo to Saxagliptin 5 mg + Metformin Withdrawal n=3 participants at risk At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.	Week 56 to 104: Non-treatment Follow-up Period n=210 participants at risk Safety monitoring continued in the Non-treatment Follow-up Period quarterly between the Week 56 and Week 104 visits.
Eye disorders Cataract	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Endocrine disorders Hypoparathyroidism	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Limb injury	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Scratch	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Skin abrasion	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.9% 1/53 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Wound complication	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Alanine aminotransferase increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Endocrine disorders Hypothyroidism	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Albumin urine present	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Aspartate aminotransferase increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Bacterial test	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Blood alkaline phosphatase increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Blood cholesterol increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Blood glucose increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Blood glucose normal	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Blood parathyroid hormone increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Blood pressure increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Blood triglycerides increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Endocrine disorders Primary hypothyroidism	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations C-telopeptide increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Crystal urine present	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Glycosylated haemoglobin increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Hepatic enzyme increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Liver function test increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Low density lipoprotein increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Mean cell haemoglobin concentration decreased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Mean cell haemoglobin decreased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Sars-cov-2 test positive	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Transaminases increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Urine albumin/creatinine ratio increased	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Vitamin d decreased	2.5% 2/81 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations Weight increased	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Investigations White blood cells urine positive	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Eye disorders Conjunctivitis allergic	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Hypertriglyceridaemia	4.9% 4/81 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Hyperuricaemia	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.9% 3/76 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Obesity	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Metabolism and nutrition disorders Vitamin d deficiency	2.5% 2/81 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.6% 2/55 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.5% 4/88 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	6.6% 5/76 • Number of events 5 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	33.3% 1/3 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Musculoskeletal and connective tissue disorders Back pain	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Eye disorders Ocular hyperaemia	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Nervous system disorders Headache	7.4% 6/81 • Number of events 7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	9.1% 5/55 • Number of events 5 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.6% 2/55 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	9.5% 2/21 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.3% 2/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Nervous system disorders Dizziness	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Nervous system disorders Somnolence	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Abdominal pain	2.5% 2/81 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.3% 2/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Nervous system disorders Syncope	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Nervous system disorders Tremor	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Psychiatric disorders Anxiety	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Psychiatric disorders Anxiety disorder	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Psychiatric disorders Depression	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Psychiatric disorders Generalised anxiety disorder	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Psychiatric disorders Insomnia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Psychiatric disorders Nervousness	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Psychiatric disorders Persistent depressive disorder	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Psychiatric disorders Tic	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Dysuria	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Haematuria	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Microalbuminuria	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.3% 2/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Nephrolithiasis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Nephropathy	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Nocturia	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Pollakiuria	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Polyuria	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Proteinuria	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Abdominal pain upper	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.6% 2/55 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Renal and urinary disorders Renal colic	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Reproductive system and breast disorders Amenorrhoea	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	9.5% 2/21 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Reproductive system and breast disorders Premenstrual pain	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	7.7% 1/13 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.9% 1/53 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	7.7% 1/13 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Acne	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Dermatitis	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Blood and lymphatic system disorders Anaemia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Colitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Dermatitis contact	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Eczema	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Erythema	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Ingrown hair	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Pruritus	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Rash	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Diarrhoea	3.7% 3/81 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.9% 3/76 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
General disorders Fatigue	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Surgical and medical procedures Adenoidectomy	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Surgical and medical procedures Nasal septal operation	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Surgical and medical procedures Sphenoid sinus operation	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Surgical and medical procedures Tonsillectomy	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Vascular disorders Hot flush	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Vascular disorders Hypertension	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Food poisoning	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Gastritis	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Nausea	3.7% 3/81 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.4% 3/88 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.3% 3/70 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Tooth impacted	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Toothache	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	7.7% 2/26 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Gastrointestinal disorders Vomiting	3.7% 3/81 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
General disorders Chest discomfort	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
General disorders Chest pain	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
General disorders Drug intolerance	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
General disorders Pain	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
General disorders Pyrexia	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
General disorders Swelling face	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Hepatobiliary disorders Hepatic steatosis	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.3% 2/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Hepatobiliary disorders Hepatomegaly	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Immune system disorders Hypersensitivity	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Immune system disorders Immunisation reaction	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Immune system disorders Seasonal allergy	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Acute sinusitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Balanitis candida	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Bronchitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Covid-19	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	6.6% 4/61 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	7.7% 1/13 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Cellulitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Chronic sinusitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Conjunctivitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Croup infectious	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Cystitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Ear infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Fungal balanitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Fungal foot infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Fungal infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Fungal skin infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Gastritis viral	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Gastroenteritis	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.3% 2/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Gastroenteritis viral	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Gastrointestinal infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Hand-foot-and-mouth disease	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Hordeolum	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Influenza	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	5.5% 3/55 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.3% 2/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.9% 3/61 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Nail infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Nasopharyngitis	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.6% 2/55 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.3% 2/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	15.4% 2/13 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.3% 3/70 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.9% 1/53 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Norovirus infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Otitis externa	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Cardiac disorders Tachycardia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Otitis media	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Otitis media bacterial	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Paronychia	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Pericoronitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Pharyngitis	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Pharyngotonsillitis	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	14.3% 1/7 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Respiratory tract infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Respiratory tract infection viral	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Rhinitis	3.7% 3/81 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Soft tissue infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Cardiac disorders Wolff-parkinson-white syndrome	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Subcutaneous abscess	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Tinea cruris	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Tinea versicolour	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Tonsillitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	14.3% 1/7 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Tonsillitis bacterial	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Tooth abscess	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Tooth infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Upper respiratory tract infection	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.3% 2/88 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	6.6% 4/61 • Number of events 4 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.6% 2/76 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	2.9% 2/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 2 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Urinary tract infection	3.7% 3/81 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.4% 3/88 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.9% 3/61 • Number of events 3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	5.3% 4/76 • Number of events 5 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	7.1% 5/70 • Number of events 6 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Viral infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Ear and labyrinth disorders Ear pain	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.8% 1/55 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Viral pharyngitis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.6% 1/61 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	4.8% 1/21 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Animal bite	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Closed globe injury	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.3% 1/76 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Fall	1.2% 1/81 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/88 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/81 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/55 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/21 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/7 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.1% 1/88 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	3.8% 1/26 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/61 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/26 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/13 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/76 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	1.4% 1/70 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/70 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/53 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	33.3% 1/3 • Number of events 1 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/3 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.	0.00% 0/210 • All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56) Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place