Trial Outcomes & Findings for Cardiovascular Intervention Improvement Telemedicine Study (NCT NCT01142908)

NCT ID: NCT01142908

Last Updated: 2023-07-27

Results Overview

Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point \[combination of administrative med data pull and self-report at assessment\]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 428 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2023-07-27

Participant Flow

Participant milestones

Measure	Pharmacist CVD The pharmacist cardiovascular (CVD) intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control The education control group - these participants will receive educational material about CVD reduction.
Overall Study STARTED	215	213
Overall Study 6 Month f/u	188	196
Overall Study COMPLETED	183	191
Overall Study NOT COMPLETED	32	22

Reasons for withdrawal

Measure	Pharmacist CVD The pharmacist cardiovascular (CVD) intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control The education control group - these participants will receive educational material about CVD reduction.
Overall Study Lost to Follow-up	19	13
Overall Study Death	1	4
Overall Study Excluded - did not meet criteria	9	5
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

Cardiovascular Intervention Improvement Telemedicine Study

Baseline characteristics by cohort

Measure	Pharmacist CVD n=215 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=213 Participants The education control group - these participants will receive educational material about CVD reduction.	Total n=428 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 8.4 • n=5 Participants	61.5 years STANDARD_DEVIATION 8.9 • n=7 Participants	61.2 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	182 Participants n=5 Participants	181 Participants n=7 Participants	363 Participants n=5 Participants
Race/Ethnicity, Customized White	93 participants n=5 Participants	106 participants n=7 Participants	199 participants n=5 Participants
Race/Ethnicity, Customized Black	111 participants n=5 Participants	102 participants n=7 Participants	213 participants n=5 Participants
Race/Ethnicity, Customized Other	10 participants n=5 Participants	4 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Refused/Missing	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	215 participants n=5 Participants	213 participants n=7 Participants	428 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Two out of the 215 participants in the Pharmacist CVD group had missing data due to not having the blood pressure component of the Framingham collected at baseline.

Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

Outcome measures

Measure	Pharmacist CVD n=213 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=213 Participants The education control group - these participants will receive educational material about CVD reduction.
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)	32.4 % 10 yr Risk Standard Deviation 18.8	31.6 % 10 yr Risk Standard Deviation 18.6

PRIMARY outcome

Timeframe: 6 months

Population: 29 out of the 215 participants in the Pharmacist CVD group and 24 of the 213 participants in the Education Control group had missing data at 6 months due to entirely missing the 6 month assessment or having missing data on one or more of the Framingham components.

Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

Outcome measures

Measure	Pharmacist CVD n=186 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=189 Participants The education control group - these participants will receive educational material about CVD reduction.
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)	30.0 % 10 yr Risk Standard Deviation 17.2	30.2 % 10 yr Risk Standard Deviation 18.7

PRIMARY outcome

Timeframe: 12 months

Population: 43 out of the 215 participants in the Pharmacist CVD group and 33 of the 213 participants in the Education Control group had missing data at 12 months due to entirely missing the 12 month assessment or having missing data on one or more of the Framingham components.

Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

Outcome measures

Measure	Pharmacist CVD n=172 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=180 Participants The education control group - these participants will receive educational material about CVD reduction.
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)	28.9 % 10 yr Risk Standard Deviation 15.5	28.4 % 10 yr Risk Standard Deviation 18.3

SECONDARY outcome

Timeframe: Baseline

Population: One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Outcome measures

Measure	Pharmacist CVD n=214 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=213 Participants The education control group - these participants will receive educational material about CVD reduction.
Mean Systolic Blood Pressure	130.6 mmHg Standard Deviation 18.5	129.7 mmHg Standard Deviation 18.8

SECONDARY outcome

Timeframe: 6 months

Population: 28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Outcome measures

Measure	Pharmacist CVD n=187 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=190 Participants The education control group - these participants will receive educational material about CVD reduction.
Mean Systolic Blood Pressure	128.3 mmHg Standard Deviation 16.5	127.7 mmHg Standard Deviation 16.8

SECONDARY outcome

Timeframe: 12 months

Population: 36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 mo. due to missing the 12 month interview entirely or blood pressure not collected at the 12 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Outcome measures

Measure	Pharmacist CVD n=179 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=183 Participants The education control group - these participants will receive educational material about CVD reduction.
Mean Systolic Blood Pressure	128.5 mmHg Standard Deviation 15.4	126.4 mmHg Standard Deviation 16.2

SECONDARY outcome

Timeframe: Baseline

Population: One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Outcome measures

Measure	Pharmacist CVD n=214 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=213 Participants The education control group - these participants will receive educational material about CVD reduction.
Mean Diastolic Blood Pressure	75.8 mmHg Standard Deviation 11.5	75.8 mmHg Standard Deviation 12.4

SECONDARY outcome

Timeframe: 6 months

Population: 28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Outcome measures

Measure	Pharmacist CVD n=187 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=190 Participants The education control group - these participants will receive educational material about CVD reduction.
Mean Diastolic Blood Pressure	74.0 mmHg Standard Deviation 11.0	74.1 mmHg Standard Deviation 11.9

SECONDARY outcome

Timeframe: 12 months

Population: 36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 months due to missing the 12 month interview entirely or blood pressure not collected at the 12 mo. assessment due to patient arm size exceeding cuff size or interview completed over the phone.

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Outcome measures

Measure	Pharmacist CVD n=179 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=183 Participants The education control group - these participants will receive educational material about CVD reduction.
Mean Diastolic Blood Pressure	73.4 mmHg Standard Deviation 10.3	73.1 mmHg Standard Deviation 10.9

SECONDARY outcome

Timeframe: Baseline

Population: 5 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to non-response of adherence items collected in the baseline interview.

First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

Outcome measures

Measure	Pharmacist CVD n=210 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=211 Participants The education control group - these participants will receive educational material about CVD reduction.
Medication Non-adherence	137 participants	110 participants

SECONDARY outcome

Timeframe: 6 months

Population: 28 out of the 215 participants in the Pharmacist CVD group and 18 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 6 month assessment or non-response of adherence items collected in the 6 month interview.

First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

Outcome measures

Measure	Pharmacist CVD n=187 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=195 Participants The education control group - these participants will receive educational material about CVD reduction.
Medication Non-adherence	92 participants	85 participants

SECONDARY outcome

Timeframe: 12 months

Population: 35 out of the 215 participants in the Pharmacist CVD group and 24 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 12 month assessment or non-response of adherence items collected in the 12 month interview.

First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

Outcome measures

Measure	Pharmacist CVD n=180 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=189 Participants The education control group - these participants will receive educational material about CVD reduction.
Medication Non-adherence	96 participants	82 participants

SECONDARY outcome

Timeframe: Baseline

Population: 4 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data due to not having cholesterol LDL collected at baseline.

Collected during interview visit by lab personnel

Outcome measures

Measure	Pharmacist CVD n=211 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=211 Participants The education control group - these participants will receive educational material about CVD reduction.
Cholesterol LDL	125.5 mg/dL Standard Deviation 37.3	123.9 mg/dL Standard Deviation 36.2

SECONDARY outcome

Timeframe: 6 months

Population: 29 out of the 215 participants in the Pharmacist CVD group and 22 out of the 213 in the Education Control group had missing cholesterol LDL at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.

Collected during interview visit by lab personnel

Outcome measures

Measure	Pharmacist CVD n=186 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=191 Participants The education control group - these participants will receive educational material about CVD reduction.
Cholesterol LDL	114.9 mg/dL Standard Deviation 34.9	118.9 mg/dL Standard Deviation 34.3

SECONDARY outcome

Timeframe: 12 months

Population: 34 out of the 215 participants in the Pharmacist CVD group and 27 out of the 213 in the Education Control group had missing cholesterol LDL at 12 months due to missing the 12 month interview entirely or not completing the lab assessment.

Collected during interview visit by lab personnel

Outcome measures

Measure	Pharmacist CVD n=181 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=186 Participants The education control group - these participants will receive educational material about CVD reduction.
Cholesterol LDL	114.4 mg/dL Standard Deviation 36.8	115.3 mg/dL Standard Deviation 34.0

SECONDARY outcome

Timeframe: Baseline

Population: 5 out of the 215 participants in the Pharmacist CVD group and 1 out of the 213 participants in the Education Control group had missing data due weight and/or height not collected at baseline.

Calculated from vitals (height & weight) obtained during interview

Outcome measures

Measure	Pharmacist CVD n=210 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=212 Participants The education control group - these participants will receive educational material about CVD reduction.
Body Mass Index	31.9 kg/m^2 Standard Deviation 5.8	31.6 kg/m^2 Standard Deviation 5.7

SECONDARY outcome

Timeframe: 6 months

Population: 30 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing body mass index at 6 months due to missing the 6 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 6 month interview.

Calculated from vitals (height & weight) obtained during interview

Outcome measures

Measure	Pharmacist CVD n=185 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=190 Participants The education control group - these participants will receive educational material about CVD reduction.
Body Mass Index	32.1 kg/m^2 Standard Deviation 6.3	31.5 kg/m^2 Standard Deviation 5.4

SECONDARY outcome

Timeframe: 12 months

Population: 39 out of the 215 participants in the Pharmacist CVD group and 31 out of the 213 in the Education Control group had missing body mass index at 12 months due to missing the 12 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 12 month interview.

Calculated from vitals (height & weight) obtained during interview

Outcome measures

Measure	Pharmacist CVD n=176 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=182 Participants The education control group - these participants will receive educational material about CVD reduction.
Body Mass Index	31.9 kg/m^2 Standard Deviation 6.0	31.6 kg/m^2 Standard Deviation 5.7

SECONDARY outcome

Timeframe: Baseline

Population: 4 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 2 out of the 86 participants in the Education Control group with diabetes at baseline had missing data due to not having HBA1C collected at baseline.

Lab values collected at interview visit by lab personnel

Outcome measures

Measure	Pharmacist CVD n=81 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=84 Participants The education control group - these participants will receive educational material about CVD reduction.
HBA1C in Diabetic Patients	8.0 percentage of glycosylated hemoglobin Standard Deviation 2.3	7.6 percentage of glycosylated hemoglobin Standard Deviation 1.7

SECONDARY outcome

Timeframe: 6 months

Population: 12 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 11 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.

Lab values collected at interview visit by lab personnel

Outcome measures

Measure	Pharmacist CVD n=73 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=75 Participants The education control group - these participants will receive educational material about CVD reduction.
HBA1C in Diabetic Patients	7.5 percentage of glycosylated hemoglobin Standard Deviation 1.8	7.7 percentage of glycosylated hemoglobin Standard Deviation 1.8

SECONDARY outcome

Timeframe: 12 months

Population: 14 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 15 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.

Lab values collected at interview visit by lab personnel

Outcome measures

Measure	Pharmacist CVD n=71 Participants The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=71 Participants The education control group - these participants will receive educational material about CVD reduction.
HBA1C in Diabetic Patients	7.5 percentage of glycosylated hemoglobin Standard Deviation 1.8	7.7 percentage of glycosylated hemoglobin Standard Deviation 1.7

Adverse Events

Pharmacist CVD

Serious events: 126 serious events

Other events: 0 other events

Deaths: 0 deaths

Education Control

Serious events: 123 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pharmacist CVD n=215 participants at risk The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Education Control n=213 participants at risk The education control group - these participants will receive educational material about CVD reduction.
Blood and lymphatic system disorders Non_Cardiac Pain	0.47% 1/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Blood and lymphatic system disorders Emergecy Room Visit	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Cardiac disorders Coronary Issues	1.4% 3/215 • Number of events 4 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	3.3% 7/213 • Number of events 8 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Cardiac disorders Emergency room visit	9.8% 21/215 • Number of events 34 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	7.0% 15/213 • Number of events 15 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Cardiac disorders Non_Cardiac Pain	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Cardiac disorders Orthopedic	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Cardiac disorders Planned Surgery	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.94% 2/213 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Cardiac disorders Study Safety Protocol	4.7% 10/215 • Number of events 10 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	6.1% 13/213 • Number of events 16 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Ear and labyrinth disorders Emergency room visit	1.4% 3/215 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	1.9% 4/213 • Number of events 6 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Ear and labyrinth disorders Infection	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Ear and labyrinth disorders Non_Cardiac Pain	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Endocrine disorders Death	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Endocrine disorders Emergency room visit	1.9% 4/215 • Number of events 7 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	4.2% 9/213 • Number of events 13 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Endocrine disorders Endocrine	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Endocrine disorders Non_Cardiac Pain	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Eye disorders Emergency room visit	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	2.3% 5/213 • Number of events 6 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Eye disorders Optometry	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.94% 2/213 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Eye disorders Planned Surgery	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Gastrointestinal disorders Emergency room visit	8.4% 18/215 • Number of events 21 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	6.1% 13/213 • Number of events 16 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Gastrointestinal disorders Gastro_Intestinal	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Gastrointestinal disorders Planned Surgery	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
General disorders Allergic Reaction (non_med SE)	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
General disorders Death	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.94% 2/213 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
General disorders Emergency room visit	6.5% 14/215 • Number of events 23 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	9.9% 21/213 • Number of events 22 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
General disorders Medication Refill	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
General disorders Neurologic	0.47% 1/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
General disorders Non_Cardiac Pain	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.94% 2/213 • Number of events 4 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
General disorders Planned Surgery	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
General disorders Psychological	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Infections and infestations Emergency room visit	10.2% 22/215 • Number of events 22 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	2.3% 5/213 • Number of events 6 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Infections and infestations Gastro_Intestinal	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Infections and infestations Infection	2.8% 6/215 • Number of events 8 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.94% 2/213 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Infections and infestations Medication Refill	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Injury, poisoning and procedural complications Emergency room visit	1.4% 3/215 • Number of events 4 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Injury, poisoning and procedural complications Non_Cardiac Pain	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Investigations Protocol Deviation	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Investigations Study Safety Protocol	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Metabolism and nutrition disorders Emergency room visit	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Musculoskeletal and connective tissue disorders Circulatory	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Musculoskeletal and connective tissue disorders Emergency room visit	12.6% 27/215 • Number of events 37 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	14.1% 30/213 • Number of events 44 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Musculoskeletal and connective tissue disorders Endocrine	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Musculoskeletal and connective tissue disorders Neurologic	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Musculoskeletal and connective tissue disorders Non_Cardiac Pain	2.3% 5/215 • Number of events 8 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	1.4% 3/213 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Musculoskeletal and connective tissue disorders Orthopedic	1.4% 3/215 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	1.9% 4/213 • Number of events 4 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dermatologic	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Emergency room visit	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Protocol Deviation	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Nervous system disorders Coronary issues	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Nervous system disorders Emergency room visit	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.94% 2/213 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Nervous system disorders Neurologic	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	1.4% 3/213 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Nervous system disorders Non_Cardiac Pain	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Psychiatric disorders Emergency room visit	2.3% 5/215 • Number of events 7 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	2.3% 5/213 • Number of events 5 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Psychiatric disorders Medication Refill	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Psychiatric disorders Non_Cardiac Pain	0.47% 1/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Psychiatric disorders Psychological	1.9% 4/215 • Number of events 4 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	1.9% 4/213 • Number of events 4 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Renal and urinary disorders Emergency room visit	1.9% 4/215 • Number of events 5 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	2.3% 5/213 • Number of events 5 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Renal and urinary disorders Endocrine	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Renal and urinary disorders Non_Cardiac Pain	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Renal and urinary disorders Planned Surgery	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Reproductive system and breast disorders Non_Cardiac Pain	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Reproductive system and breast disorders Emergency room visit	1.4% 3/215 • Number of events 4 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Respiratory, thoracic and mediastinal disorders Death	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Respiratory, thoracic and mediastinal disorders Emergency room visit	7.4% 16/215 • Number of events 21 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	5.6% 12/213 • Number of events 14 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Respiratory, thoracic and mediastinal disorders Infection	0.47% 1/215 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Respiratory, thoracic and mediastinal disorders Pulmonary	0.93% 2/215 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	1.4% 3/213 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Skin and subcutaneous tissue disorders Dermatologic	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.94% 2/213 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Skin and subcutaneous tissue disorders Emergency room visit	2.3% 5/215 • Number of events 7 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	2.8% 6/213 • Number of events 8 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Skin and subcutaneous tissue disorders Infection	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	1.4% 3/213 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Social circumstances Emergency room visit	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Surgical and medical procedures Coronary issues	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Surgical and medical procedures Emergency room visit	0.93% 2/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Surgical and medical procedures Gastro_Intestinal	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Surgical and medical procedures Infection	0.00% 0/215 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Surgical and medical procedures Orthopedic	1.4% 3/215 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Surgical and medical procedures Planned Surgery	8.4% 18/215 • Number of events 19 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	4.2% 9/213 • Number of events 10 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Surgical and medical procedures Pulmonary	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Vascular disorders Circulatory	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.00% 0/213 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Vascular disorders Coronary issues	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Vascular disorders Emergency room visit	0.47% 1/215 • Number of events 2 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	1.4% 3/213 • Number of events 3 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Vascular disorders Neurologic	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Vascular disorders Planned Surgery	0.47% 1/215 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.	0.47% 1/213 • Number of events 1 • Adverse events were collected through out the study from baseline thru completion. Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.

Other adverse events

Adverse event data not reported

Additional Information

Hayden B. Bosworth, PhD, Assoc Dir, Durham HSR&D COIN

Veterans Administration HSRD, Durham COIN

Phone: 919-286-0411

Email: hayden.bosworth@va.gov

Results disclosure agreements

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