Trial Outcomes & Findings for Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood (NCT NCT01619176)

NCT ID: NCT01619176

Last Updated: 2023-11-13

Results Overview

ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: From baseline to 3 weeks
• Results posted on: 2023-11-13

Participant Flow

Quality of biological sampling was not good enough to grant production of quality omic data

Participant milestones

Measure	Acupuncture Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
Overall Study STARTED	6	4
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The sum does not match the total due to missing data

Baseline characteristics by cohort

Measure	Acupuncture n=6 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months	Total n=10 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 13.08 • n=6 Participants	48.0 years STANDARD_DEVIATION 10.3 • n=4 Participants	48.4 years STANDARD_DEVIATION 12.4 • n=10 Participants
Sex: Female, Male Female	6 Participants n=6 Participants	4 Participants n=4 Participants	10 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=10 Participants
Region of Enrollment China	6 Participants n=6 Participants	4 Participants n=4 Participants	10 Participants n=10 Participants
RF(IU/mL)	246.25 IU/mL STANDARD_DEVIATION 235.3 • n=6 Participants	382.4 IU/mL STANDARD_DEVIATION 409.1 • n=4 Participants	314.3 IU/mL STANDARD_DEVIATION 317.4 • n=10 Participants
CRP(mg/L)	9.8 mg/L STANDARD_DEVIATION 5.3 • n=3 Participants • The sum does not match the total due to missing data	24.6 mg/L STANDARD_DEVIATION 22.3 • n=4 Participants • The sum does not match the total due to missing data	18.27 mg/L STANDARD_DEVIATION 17.9 • n=7 Participants • The sum does not match the total due to missing data
ESR（mm/h)	53.2 mm/h STANDARD_DEVIATION 45.5 • n=6 Participants	71.2 mm/h STANDARD_DEVIATION 60.2 • n=4 Participants	60.4 mm/h STANDARD_DEVIATION 49.4 • n=10 Participants
hemoglobin(g/L)	119.5 g/L STANDARD_DEVIATION 13.1 • n=6 Participants	113.5 g/L STANDARD_DEVIATION 24.1 • n=4 Participants	117.1 g/L STANDARD_DEVIATION 16.4 • n=10 Participants
White cell number(10^9 cells/L)	6.0 10^9 cells/L STANDARD_DEVIATION 1.8 • n=6 Participants	5.2 10^9 cells/L STANDARD_DEVIATION 3.6 • n=4 Participants	5.7 10^9 cells/L STANDARD_DEVIATION 2.4 • n=10 Participants
neutrophile granulocyte(%)	61 % of cells STANDARD_DEVIATION 6.5 • n=6 Participants	69.0 % of cells STANDARD_DEVIATION 6.1 • n=4 Participants	64.2 % of cells STANDARD_DEVIATION 6.9 • n=10 Participants
Lymphocyte(%)	30.3 % of cells STANDARD_DEVIATION 6.6 • n=6 Participants	21.0 % of cells STANDARD_DEVIATION 3.2 • n=4 Participants	26.6 % of cells STANDARD_DEVIATION 7.1 • n=10 Participants

PRIMARY outcome

Timeframe: From baseline to 3 weeks

ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:

acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire

The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

Outcome measures

Measure	Acupuncture n=2 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
ACR20 Response Rate at 3 Weeks	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From baseline to three months

ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:

acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire

The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

Outcome measures

Measure	Acupuncture n=6 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
ACR20 Response Rate at 3 Months	5 Participants	3 Participants

SECONDARY outcome

Timeframe: From baseline to 3 weeks

ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:

acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire

The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

Outcome measures

Measure	Acupuncture n=2 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
ACR50 Response Rate at 3 Weeks	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From baseline to three months

ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:

acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire

The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

Outcome measures

Measure	Acupuncture n=6 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
ACR50 Response Rate at 3 Months	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From baseline to 3 weeks

ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:

acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire

The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

Outcome measures

Measure	Acupuncture n=2 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
ACR70 Response Rate at 3 Weeks	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to three months

ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:

acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire

The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

Outcome measures

Measure	Acupuncture n=6 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
ACR70 Response Rate at 3 Months	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At baseline

The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.

The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 2.6-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease

Outcome measures

Measure	Acupuncture n=6 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
DAS28 at Baseline	4.98 units on a scale Standard Deviation 1.13	6.8 units on a scale Standard Deviation 1.97

SECONDARY outcome

Timeframe: At 3 weeks

The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.

The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease

Outcome measures

Measure	Acupuncture n=2 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
DAS28 at 3 Weeks	5 units on a scale Standard Deviation 0.14	5.27 units on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: At 3 months

The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.

The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease

Outcome measures

Measure	Acupuncture n=6 Participants Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.	Control n=4 Participants Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months
DAS28 at 3 Months	3.85 units on a scale Standard Deviation 0.59	4.5 units on a scale Standard Deviation 0.6

Adverse Events

Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

DR. Christine Nardini

CNR IAC

Phone: +393386947833

Email: christine.nardini.rsrc@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee If discussion include scientific publication there is no restriction
• Publication restrictions are in place

Restriction type: OTHER