Trial Outcomes & Findings for Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery (NCT NCT03485352)

NCT ID: NCT03485352

Last Updated: 2024-04-01

Results Overview

Anthropometric assessment will be evaluated using weight (kg).

• Recruitment status: COMPLETED
• Target enrollment: 122 participants
• Primary outcome timeframe: Baseline, 3 and 6 months
• Results posted on: 2024-04-01

Participant Flow

Participant milestones

Measure	Bariatric Surgery Patients Patients undergoing bariatric surgery (sleeve or Bypass) 28 male and 94 woman with mean age of 33 years old.
Overall Study STARTED	122
Overall Study 3 Months	117
Overall Study COMPLETED	113
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Bariatric Surgery Patients Patients undergoing bariatric surgery (sleeve or Bypass) 28 male and 94 woman with mean age of 33 years old.
Overall Study Lost to Follow-up	9

Baseline Characteristics

The participants were categorised as follows: initially, the mean exposure to SJL of the three assessment periods was calculated. Subsequently, the median of this distribution was determined and used to categorise the participants into two groups: large exposure to SJL (mean exposure > median) or small exposure to SJL (mean exposure ≤ median

Baseline characteristics by cohort

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%)	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%)	Total n=122 Participants Total of all reporting groups
Age, Continuous	33.5 years n=60 Participants • The participants were categorised as follows: initially, the mean exposure to SJL of the three assessment periods was calculated. Subsequently, the median of this distribution was determined and used to categorise the participants into two groups: large exposure to SJL (mean exposure \> median) or small exposure to SJL (mean exposure ≤ median	33 years n=62 Participants • The participants were categorised as follows: initially, the mean exposure to SJL of the three assessment periods was calculated. Subsequently, the median of this distribution was determined and used to categorise the participants into two groups: large exposure to SJL (mean exposure \> median) or small exposure to SJL (mean exposure ≤ median	33 years n=122 Participants • The participants were categorised as follows: initially, the mean exposure to SJL of the three assessment periods was calculated. Subsequently, the median of this distribution was determined and used to categorise the participants into two groups: large exposure to SJL (mean exposure \> median) or small exposure to SJL (mean exposure ≤ median
Sex: Female, Male Female	48 Participants n=60 Participants	46 Participants n=62 Participants	94 Participants n=122 Participants
Sex: Female, Male Male	12 Participants n=60 Participants	16 Participants n=62 Participants	28 Participants n=122 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Social jetlag exposure	67 Minutes n=60 Participants	67 Minutes n=62 Participants	67 Minutes n=122 Participants

PRIMARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of weight in the preoperative evaluation and in the third and sixth months after the surgical intervention.

Anthropometric assessment will be evaluated using weight (kg).

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Weight in Kg Baseline	111.4 Kg Standard Error 2.1	116.4 Kg Standard Error 3.3
Weight in Kg 3 months	89.7 Kg Standard Error 1.7	93.5 Kg Standard Error 2.7
Weight in Kg 6 months	77.5 Kg Standard Error 1.5	84.2 Kg Standard Error 2.6

PRIMARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of BMI in the preoperative evaluation and in the third and sixth months after the surgical intervention.

Anthropometric assessment will be evaluated using BMI (kg/m²).

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
BMI in Kg/m² Baseline	40.8 Kg/m² Standard Error 0.4	41.8 Kg/m² Standard Error 0.8
BMI in Kg/m² 3 months	32.9 Kg/m² Standard Error 0.4	33.6 Kg/m² Standard Error 0.7
BMI in Kg/m² 6 months	28.7 Kg/m² Standard Error 0.4	30.2 Kg/m² Standard Error 0.7

PRIMARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of waist circumference in the preoperative evaluation and in the third and sixth months after the surgical intervention.

Anthropometric assessment will be evaluated using waist circumference (cm)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Waist Circumference in Centimeters (cm) Baseline	109.3 Centimeters Standard Error 1.4	110.0 Centimeters Standard Error 1.7
Waist Circumference in Centimeters (cm) 3 months	94.1 Centimeters Standard Error 1.2	95.1 Centimeters Standard Error 1.4
Waist Circumference in Centimeters (cm) 6 months	85.5 Centimeters Standard Error 1.1	88.4 Centimeters Standard Error 1.4

PRIMARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of hip circumference in the preoperative evaluation and in the third and sixth months after the surgical intervention.

Anthropometric assessment will be evaluated using hip circumference (cm)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Hip Circumference in Centimeters (cm) Baseline	128.9 Centimeters Standard Error 1.1	131.4 Centimeters Standard Error 1.7
Hip Circumference in Centimeters (cm) 3 months	114.9 Centimeters Standard Error 1.1	117.8 Centimeters Standard Error 1.7
Hip Circumference in Centimeters (cm) 6 months	105.8 Centimeters Standard Error 1.0	109.9 Centimeters Standard Error 1.6

PRIMARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of neck circumference in the preoperative evaluation and in the third and sixth months after the surgical intervention.

Anthropometric assessment will be evaluated using neck circumference (cm)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Neck Circumference in Centimeters (cm) Baseline	39.2 Centimeters Standard Error 0.4	39.4 Centimeters Standard Error 0.5
Neck Circumference in Centimeters (cm) 3 months	36.0 Centimeters Standard Error 0.4	36.3 Centimeters Standard Error 0.4
Neck Circumference in Centimeters (cm) 6 months	34.4 Centimeters Standard Error 0.3	35.1 Centimeters Standard Error 0.4

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of fasting glucose in the preoperative evaluation and sixth months after the surgical intervention.

Metabolic parameters will be evaluated using fasting glucose (mg/dl)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Metabolic Parameters - Fasting Glucose (mg/dl) Baseline	99.0 mg/dl Standard Error 1.7	101.2 mg/dl Standard Error 3.6
Metabolic Parameters - Fasting Glucose (mg/dl) 6 months	84.5 mg/dl Standard Error 1.1	83.3 mg/dl Standard Error 0.8

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of insulin in the preoperative evaluation and sixth months after the surgical intervention.

Metabolic parameters will be evaluated using insulin (mg/dl)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Metabolic Parameters - Insulin (mg/dl) Baseline	27.0 mg/dl Standard Error 2.1	25.2 mg/dl Standard Error 1.6
Metabolic Parameters - Insulin (mg/dl) 6 months	8.8 mg/dl Standard Error 0.9	10.5 mg/dl Standard Error 0.6

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of HOMA IR in the preoperative evaluation and sixth months after the surgical intervention.

Values of metabolic parameters will be evaluated using Homeostasis model assessment for beta-cell function (HOMA - IR) according to the standard assessment measurement in mg/dl. Higher values reflect worse insulin resistance

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR) Baseline	6.7 mg/dl Standard Error 0.5	6.2 mg/dl Standard Error 0.4
Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR) 6 months	1.8 mg/dl Standard Error 0.2	2.1 mg/dl Standard Error 0.1

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of cholesterol in the preoperative evaluation and sixth months after the surgical intervention.

Metabolic parameters will be evaluated using Cholesterol (mg/dl)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Metabolic Parameters - Cholesterol (mg/dl) Baseline	201.6 mg/dl Standard Error 5.3	203.9 mg/dl Standard Error 5.4
Metabolic Parameters - Cholesterol (mg/dl) 6 months	157.0 mg/dl Standard Error 4.2	159.5 mg/dl Standard Error 4.6

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of HDL in the preoperative evaluation and sixth months after the surgical intervention.

Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl) Baseline	51.4 mg/dl Standard Error 1.7	47.6 mg/dl Standard Error 1.6
Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl) 6 months	52.1 mg/dl Standard Error 1.6	47.1 mg/dl Standard Error 1.5

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of LDL in the preoperative evaluation and sixth months after the surgical intervention.

Metabolic parameters will be evaluated using low density lipoprotein cholesterol (LDL -mg/dl)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl) Baseline	118.0 mg/dl Standard Error 4.4	119.8 mg/dl Standard Error 4.3
Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl) 6 months	86.0 mg/dl Standard Error 3.5	92.9 mg/dl Standard Error 3.8

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of VLDL in the preoperative evaluation and sixth months after the surgical intervention.

Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl) Baseline	32.2 mg/dl Standard Error 2.6	36.4 mg/dl Standard Error 2.9
Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl) 6 months	19.3 mg/dl Standard Error 0.9	19.4 mg/dl Standard Error 1.1

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of triglycerides in the preoperative evaluation and sixth months after the surgical intervention.

Metabolic parameters will be evaluated using Triglycerides (mg/dl)

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Metabolic Parameters - Triglycerides (mg/dl) 6 months	98.8 mg/dl Standard Error 5.7	96.0 mg/dl Standard Error 4.6
Metabolic Parameters - Triglycerides (mg/dl) Baseline	162.9 mg/dl Standard Error 10.6	162.3 mg/dl Standard Error 9.0

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of calories in the preoperative evaluation and in the third and sixth months after the surgical intervention.

The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Food Consumption - Calories (Grams/Day) Baseline	2185.0 grams/day Standard Error 95.5	2565.6 grams/day Standard Error 130.0
Food Consumption - Calories (Grams/Day) 3 months	823.8 grams/day Standard Error 32.0	889.7 grams/day Standard Error 34.2
Food Consumption - Calories (Grams/Day) 6 months	937.7 grams/day Standard Error 30.6	1091.9 grams/day Standard Error 39.0

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of the carbohydrate in the preoperative evaluation and in the third and sixth months after the surgical intervention.

The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Food Consumption - Carbohydrate (Grams/Day) Baseline	229.0 grams/day Standard Error 9.4	261.4 grams/day Standard Error 13.7
Food Consumption - Carbohydrate (Grams/Day) 3 months	61 grams/day Standard Error 3.1	70.7 grams/day Standard Error 3.7
Food Consumption - Carbohydrate (Grams/Day) 6 months	68.8 grams/day Standard Error 3.5	77.7 grams/day Standard Error 3.8

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of total fat in the preoperative evaluation and in the third and sixth months after the surgical intervention.

The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Food Consumption - Total Fat (Grams/Day) Baseline	97.3 grams/day Standard Error 5.6	116.5 grams/day Standard Error 7.4
Food Consumption - Total Fat (Grams/Day) 3 months	32.2 grams/day Standard Error 1.7	33.2 grams/day Standard Error 1.9
Food Consumption - Total Fat (Grams/Day) 6 months	40.2 grams/day Standard Error 1.7	49.5 grams/day Standard Error 2.4

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of Polyunsaturated fat in the preoperative evaluation and in the third and sixth months after the surgical intervention.

The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Food Consumption - Polyunsaturated Fat (Grams/Day) Baseline	12.9 grams/day Standard Error 0.9	15.9 grams/day Standard Error 1.2
Food Consumption - Polyunsaturated Fat (Grams/Day) 3 months	4.5 grams/day Standard Error 0.2	5.0 grams/day Standard Error 0.3
Food Consumption - Polyunsaturated Fat (Grams/Day) 6 months	5.9 grams/day Standard Error 0.3	7.8 grams/day Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of Monounsaturated fat in the preoperative evaluation and in the third and sixth months after the surgical intervention.

The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).

Outcome measures

Measure	Small SJL n=60 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) and aged 33 years old.	Large SJL n=62 Participants Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) and aged 33 years old.
Food Consumption - Monounsaturated Fat (Grams/Day) Baseline	30.1 grams/day Standard Error 1.9	34.5 grams/day Standard Error 1.9
Food Consumption - Monounsaturated Fat (Grams/Day) 3 months	10.0 grams/day Standard Error 0.6	10.2 grams/day Standard Error 0.6
Food Consumption - Monounsaturated Fat (Grams/Day) 6 months	12.8 grams/day Standard Error 0.5	15.6 grams/day Standard Error 0.9

Adverse Events

Small and Large Social Jetlag

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mrs Cibele Crispim

Federal University of Uberlandia

Phone: 55 34 3218-2084

Email: cibelecrispim@gmail.com

Results disclosure agreements

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