Trial Outcomes & Findings for Thiazolidinedione Intervention With Vitamin D Evaluation (NCT NCT00879970)

NCT ID: NCT00879970

Last Updated: 2017-04-18

Results Overview

An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function\[s\] due to disturbance in the blood supply to the brain not leading to death).

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 1332 participants
• Primary outcome timeframe: From Randomization at Visit 3 up to the Final Visit (average of 162 days)
• Results posted on: 2017-04-18

Participant Flow

1332 participants were included in the TZD randomization, and 1221 of 1332 participants were included in the Vitamin D randomization.

Randomization occurred subsequent to a 3-week rosiglitazone (RSG) and vitamin D Single-blind Run-in Phase to assess compliance and tolerability. Participants received an RSG tablet (4 milligrams [mg]) and a vitamin D tablet (1000 international units [IU]) once a day.

Participant milestones

Measure	Placebo Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D 1,000 IU/day administered for a mean duration of 162 days.
Period 1 TZD Randomization STARTED	541	392	399	0	0
Period 1 TZD Randomization COMPLETED	533	388	393	0	0
Period 1 TZD Randomization NOT COMPLETED	8	4	6	0	0
Period 2 Vitamin D Randomization STARTED	0	0	0	614	607
Period 2 Vitamin D Randomization COMPLETED	0	0	0	610	600
Period 2 Vitamin D Randomization NOT COMPLETED	0	0	0	4	7

Reasons for withdrawal

Measure	Placebo Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D 1,000 IU/day administered for a mean duration of 162 days.
Period 1 TZD Randomization Refused to Attend Final Visit	3	3	4	0	0
Period 1 TZD Randomization Lost to Follow-up	1	0	1	0	0
Period 1 TZD Randomization Death	2	1	0	0	0
Period 1 TZD Randomization Final or Study Hold Visits Not Completed	2	0	1	0	0
Period 2 Vitamin D Randomization Refused to Attend Final Visit	0	0	0	2	6
Period 2 Vitamin D Randomization Lost to Follow-up	0	0	0	0	1
Period 2 Vitamin D Randomization Death	0	0	0	2	0

Baseline Characteristics

Thiazolidinedione Intervention With Vitamin D Evaluation

Baseline characteristics by cohort

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Total n=1332 Participants Total of all reporting groups
Age, Continuous	66.4 Years STANDARD_DEVIATION 6.8 • n=5 Participants	66.3 Years STANDARD_DEVIATION 6.6 • n=7 Participants	66.5 Years STANDARD_DEVIATION 6.4 • n=5 Participants	66.4 Years STANDARD_DEVIATION 6.6 • n=4 Participants
Sex: Female, Male Female	220 Participants n=5 Participants	167 Participants n=7 Participants	161 Participants n=5 Participants	548 Participants n=4 Participants
Sex: Female, Male Male	321 Participants n=5 Participants	225 Participants n=7 Participants	238 Participants n=5 Participants	784 Participants n=4 Participants
Race/Ethnicity, Customized European/ Caucasian/ White	330 participants n=5 Participants	241 participants n=7 Participants	255 participants n=5 Participants	826 participants n=4 Participants
Race/Ethnicity, Customized Unknown	53 participants n=5 Participants	34 participants n=7 Participants	35 participants n=5 Participants	122 participants n=4 Participants
Race/Ethnicity, Customized South Asian	63 participants n=5 Participants	46 participants n=7 Participants	48 participants n=5 Participants	157 participants n=4 Participants
Race/Ethnicity, Customized Black African	45 participants n=5 Participants	35 participants n=7 Participants	26 participants n=5 Participants	106 participants n=4 Participants
Race/Ethnicity, Customized Native South American	33 participants n=5 Participants	26 participants n=7 Participants	24 participants n=5 Participants	83 participants n=4 Participants
Race/Ethnicity, Customized Other Asian	10 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	22 participants n=4 Participants
Race/Ethnicity, Customized Native North American	1 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	7 participants n=4 Participants
Race/Ethnicity, Customized Japanese	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Arab/ Persian	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian/ Australian or Other Asian Pacific	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Malays	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Sub-Saharan African	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Missing	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants

PRIMARY outcome

Timeframe: From Randomization at Visit 3 up to the Final Visit (average of 162 days)

Population: Intent-to-Treat (ITT) Population: all randomized participants

An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function[s] due to disturbance in the blood supply to the brain not leading to death).

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) CV Death/Non-Fatal MI/Non-Fatal Stroke	5 participants	2 participants	1 participants	3 participants	2 participants
Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) CV Death	1 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) Non-Fatal MI	2 participants	0 participants	1 participants	1 participants	1 participants
Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) Non-Fatal Stroke	2 participants	2 participants	0 participants	1 participants	1 participants

PRIMARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D Death or serious cancer	6 participants	3 participants	1 participants	3 participants	2 participants
Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D All death	4 participants	1 participants	1 participants	2 participants	0 participants
Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D Serious cancer	2 participants	2 participants	0 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

Revascularization is defined as any surgical procedure for the provision of a new, additional, or augmented blood supply to heart muscle. Data regarding the need for any revascularization were adjudicated by the EAC and sent to the data monitoring committee (IDMC) on a regular basis for unblinded review.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With Any Revascularization	6 participants	3 participants	5 participants	7 participants	5 participants

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

Data regarding the need for hospitalization for any reason were collected and were then forwarded to the independent data monitoring committee (IDMC) on a regular basis for unblinded review.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With Need for Hospitalization for Any Reason	31 participants	16 participants	24 participants	19 participants	32 participants

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

CHF is a condition in which the heart is not able to pump adequate blood to meet the body's needs. Shortness of breath is defined as difficulty in breathing. Pneumonia is an infection of the lungs, caused by various microorganisms. Angina is defined as severe chest pain due to lack of adequate blood supply of the heart muscle because of obstruction/spasm of the heart's blood vessels. Data regarding the need for hospitalization due to any of these reasons were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina Angina	3 participants	1 participants	1 participants	NA participants Angina was not analyzed in the Vitamin D arm.	NA participants Angina was not analyzed in the Vitamin D arm.
Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina CHF	1 participants	2 participants	0 participants	0 participants	2 participants
Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina Shortness of breath	0 participants	1 participants	2 participants	0 participants	1 participants
Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina Pneumonia	0 participants	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

The components of the composite microvascular outcome are retinopathy, decline in eGFR, vitrectomy, and renal replacement surgery. Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data regarding the number of participants with changes in micro blood vessels (composite microvascular outcome) were collected at each visit.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With Composite Microvascular Outcome	21 participants	8 participants	9 participants	18 participants	18 participants

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data on the number of participants with all of these microvascular outcomes were collected at each visit. Data regarding the number of participants with these microvascular outcomes were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy Renal Replacement Therapy	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy Retinopathy Requiring Laser Therapy	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy Decline in eGFR >=30%	20 participants	8 participants	9 participants	18 participants	18 participants
Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy Vitrectomy	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

Severe hypoglycemia is defined as hypoglycemia requiring assistance from another person with either a documented plasma glucose <=36 mg/deciliter (2.0 millimole per liter [mmol/L]) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Hypoglycemia data were obtained from outcomes reported by the site. Data regarding hypoglycemia were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia)	0 participants	2 participants	1 participants	0 participants	3 participants

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

Clinical proteinuria is defined as a laboratory detection of urinary protein excretion > 0.5 grams (g) per 24 hours; spot urine analysis for albumin:creatinine ratio >=300 milligrams/g; timed urine collection for albumin excretion >=200 µg/minute or >=300 mg/24 hours. Clinical proteinuria data were obtained from outcomes reported by the site.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With Clinical Proteinuria	1 participants	0 participants	0 participants	NA participants Proteinuria was not analyzed in the Vitamin D arm.	NA participants Proteinuria was not analyzed in the Vitamin D arm.

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

Fracture is defined as a medical condition in which there is a break in the continuity of the bone. Fractures are defined as those breaks that are self reported plus confirmed by an X-ray. Data regarding all occurrences of any fracture were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With a Fracture	2 participants	2 participants	3 participants	3 participants	3 participants

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population

Liver function tests are groups of clinical biochemistry laboratory blood assays designed to give information about the health of the liver. "Liver function test abnormal" and "hepatic enzyme increased" were obtained from adverse event data as reported by investigators based on the reference range of the reporting local laboratory methodology. The vitamin D arm was not analyzed for this outcome measure.

Outcome measures

Measure	Placebo n=541 Participants Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone (PIO) n=392 Participants PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone (RSG) n=399 Participants RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 Participants Vitamin D placebo administered for a mean duration of 162 days.	Vitamin D n=607 Participants 1,000 IU/day administered for a mean duration of 162 days.
Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests	1 participants	0 participants	1 participants	NA participants The vitamin D arm was not analyzed for this outcome measure.	NA participants The vitamin D arm was not analyzed for this outcome measure.

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.

CD is equivalent to a difference of >=1.5 units on the Digit Symbol Substitution Test (DSST) score. The DSST is a neuropsychological test sensitive to brain damage, a serious loss of cognitive ability, age, and depression. It consists of digit-symbol pairs, followed by a list of digits. Under each digit the participant was asked to write the corresponding symbol as quickly as possible. The number of correct symbols within the allowed time (90 or 120 seconds) was measured in units (one correct score equals one unit).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.

Erectile dysfunction (ED) is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance. ED was assessed by using the International Index of Erectile Dysfunction (IIED) questionnaire. This standardized and validated 15-item self-evaluation scale provides pre- and post-treatment clinic evaluations of erectile and orgasmic function, sexual desire, satisfaction with sexual intercourse, and general satisfaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.

Quality of life (QoL) was assessed by using the Euro-QoL (EQ)-5D, a short questionnaire used for measuring health-related QoL. The preference weights are elicited by asking participants to place hypothetical health states on a visual analogue scale from "0" to "1", whereby a score of "1" represents the best health state imaginable and "0" represents a health state equivalent to being dead. Negative states are those worse than being dead.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)

Population: ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.

CF was assessed with the 30-point (pt) MoCA test, involving a short-term memory recall task (T) (5 pts), a clock-drawing T (3 pts), a 3-dimensional cube copy (1 pt), a trail-making B T (1 pt), a phonemic fluency T (1 pt), a 2-item verbal abstraction T (2 pts), an attention T (1 pt), a serial subtraction T (3 pts), digits forward/ backward (1 pt each), a 3-item confrontation naming T (3 pts), repetition of 2 syntactically complex sentences (2 pts), and orientation to time/ place (6 pts). A score of 26 or above is normal.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 7 serious events

Other events: 36 other events

Deaths: 0 deaths

Pioglitazone

Serious events: 5 serious events

Other events: 35 other events

Deaths: 0 deaths

Rosiglitazone

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Vitamin D Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=541 participants at risk Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone n=392 participants at risk PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone n=399 participants at risk RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 participants at risk Vitamin D placebo administered for a mean duration of 162 days	Vitamin D n=607 participants at risk 1,000 IU/day administered for a mean duration of 162 days.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.33% 2/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Surgical and medical procedures Angioplasty	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.16% 1/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Vascular disorders Aortic aneurysm	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Surgical and medical procedures Aortic aneurysm repair	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.16% 1/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.16% 1/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Respiratory, thoracic and mediastinal disorders Bronchial disorder	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.16% 1/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.16% 1/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Infections and infestations Chronic sinusitis	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.16% 1/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Renal and urinary disorders Hydronephrosis	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.16% 1/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Intestinal prolapse	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.16% 1/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Multi-organ failure	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Skin and subcutaneous tissue disorders Pruritis allergic	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.16% 1/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/614 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/607 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.

Other adverse events

Measure	Placebo n=541 participants at risk Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.	Pioglitazone n=392 participants at risk PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.	Rosiglitazone n=399 participants at risk RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.	Vitamin D Placebo n=614 participants at risk Vitamin D placebo administered for a mean duration of 162 days	Vitamin D n=607 participants at risk 1,000 IU/day administered for a mean duration of 162 days.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Cardiac disorders Angina pectoris	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Cardiac disorders Cardiac failure	0.55% 3/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.51% 2/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Cardiac disorders Myocardial infarction	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Cardiac disorders Palpitations	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Cardiac disorders Right ventricular failure	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Cardiac disorders Tachycardia	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Cardiac disorders Ventricular tachycardia	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Ear and labyrinth disorders Vertigo	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Eye disorders Vision blurred	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Abdominal discomfort	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Abdominal distension	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.50% 2/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Abdominal pain	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.51% 2/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Constipation	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.77% 3/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Crohn's disease	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Diarrhea	0.37% 2/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.77% 3/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Dry mouth	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Dyspepsia	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.51% 2/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Dysphagia	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Flatulence	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Nausea	0.37% 2/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.51% 2/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Peptic ulcer	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Gastrointestinal disorders Vomiting	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Asthenia	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Chest pain	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.50% 2/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Drug intolerance	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Fatigue	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.51% 2/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Malaise	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.77% 3/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Edema	0.37% 2/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	1.3% 5/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Edema peripheral	0.74% 4/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	2.0% 8/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Swelling	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
General disorders Temperature intolerance	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Infections and infestations Urinary tract infection	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Cardiac stress test abnormal	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Catheterisation cardiac	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Echocardiogram abnormal	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Ejection fraction abnormal	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Ejection fraction decreased	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Electrocardiogram abnormal	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Electrocardiogram change	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Glycosylated hemoglobin increased	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Hepatic enzyme increased	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Liver function test abnormal	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Investigations Weight increased	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.51% 2/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.50% 2/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Metabolism and nutrition disorders Decreased appetite	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Metabolism and nutrition disorders Fluid overload	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Metabolism and nutrition disorders Fluid retention	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Metabolism and nutrition disorders Hypoglycemia	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.51% 2/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.51% 2/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Nervous system disorders Renal cancer	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Nervous system disorders Cerebrovascular accident	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Nervous system disorders Dizziness	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.51% 2/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Nervous system disorders Syncope	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Renal and urinary disorders Bladder obstruction	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Renal and urinary disorders Chromaturia	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Renal and urinary disorders Hydronephrosis	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.77% 3/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	1.0% 4/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Skin and subcutaneous tissue disorders Erythema	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.26% 1/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Skin and subcutaneous tissue disorders Skin discoloration	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.25% 1/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Surgical and medical procedures Hospitalization	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Surgical and medical procedures Surgery	0.18% 1/541 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/392 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	0.00% 0/399 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.	— 0/0 • 162 days for the TZD arm; 130 days for the vitamin D arm Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.

Additional Information

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Results disclosure agreements

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