Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105) (NCT NCT01756079)
NCT ID: NCT01756079
Last Updated: 2018-09-05
Results Overview
Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (\<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
Week 72 (24 weeks after end of treatment)
Results posted on
2018-09-05
Participant Flow
A total of 130 participants were screened. Sixty participants passed screening, but 2 of these participants were excluded before assignment because standard of care treatment was not received during the Lead-in Period.
Participant milestones
| Measure |
Overall Participants
Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
|
|---|---|
|
Lead-in: Day 0 to Week 4
STARTED
|
58
|
|
Lead-in: Day 0 to Week 4
COMPLETED
|
58
|
|
Lead-in: Day 0 to Week 4
NOT COMPLETED
|
0
|
|
Treatment / Follow-up: Week 4 to Week 72
STARTED
|
58
|
|
Treatment / Follow-up: Week 4 to Week 72
Treated in Treatment Period
|
54
|
|
Treatment / Follow-up: Week 4 to Week 72
COMPLETED
|
23
|
|
Treatment / Follow-up: Week 4 to Week 72
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Overall Participants
Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
|
|---|---|
|
Treatment / Follow-up: Week 4 to Week 72
Withdrawal by Subject
|
4
|
|
Treatment / Follow-up: Week 4 to Week 72
Adverse Event
|
5
|
|
Treatment / Follow-up: Week 4 to Week 72
No information available
|
2
|
|
Treatment / Follow-up: Week 4 to Week 72
Lack of Efficacy
|
20
|
|
Treatment / Follow-up: Week 4 to Week 72
No boceprevir during Treatment Period
|
4
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)
Baseline characteristics by cohort
| Measure |
Overall Participants
n=58 Participants
Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
|
|---|---|
|
Age, Continuous
|
59.3 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 72 (24 weeks after end of treatment)Population: The Intent to Treat population included all participants who received at least 1 administration of boceprevir during the Treatment Period.
Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (\<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.
Outcome measures
| Measure |
Overall Participants
n=54 Participants
Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
|
|---|---|
|
Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)
|
35.2 Percentage of participants
Interval 22.7 to 49.4
|
PRIMARY outcome
Timeframe: Up to 48 weeks (Lead-in and Treatment Periods)Population: Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period
Adverse events were monitored during the Lead-in and Treatment Periods
Outcome measures
| Measure |
Overall Participants
n=54 Participants
Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
|
|---|---|
|
Percentage of Participants With One or More Adverse Events
|
98.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 48 weeks (Lead-in and Treatment Periods)Population: Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period
Adverse events were monitored during the Lead-in and Treatment Periods
Outcome measures
| Measure |
Overall Participants
n=54 Participants
Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
|
|---|---|
|
Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication
|
9.3 Percentage of participants
|
Adverse Events
Overall Participants: Lead-in, Treatment and Follow-up
Serious events: 10 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall Participants: Lead-in, Treatment and Follow-up
n=58 participants at risk
Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
4/58 • Number of events 5 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
2/58 • Number of events 2 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
General disorders
Asthenia
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
General disorders
Chest pain
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
General disorders
Hyperpyrexia
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
General disorders
Pyrexia
|
3.4%
2/58 • Number of events 2 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Infections and infestations
Parathyroid fever
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Infections and infestations
Pneumonia
|
3.4%
2/58 • Number of events 2 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Nervous system disorders
Encephalopathy
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Nervous system disorders
Headache
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Psychiatric disorders
Confusional state
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Renal and urinary disorders
Renal impairment
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Vascular disorders
Hypotension
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Vascular disorders
Peripheral artery stenosis
|
1.7%
1/58 • Number of events 1 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
Other adverse events
| Measure |
Overall Participants: Lead-in, Treatment and Follow-up
n=58 participants at risk
Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.9%
15/58 • Number of events 15 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.1%
7/58 • Number of events 7 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Blood and lymphatic system disorders
Anaemia
|
75.9%
44/58 • Number of events 82 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Gastrointestinal disorders
Nausea
|
20.7%
12/58 • Number of events 13 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
General disorders
Adverse drug reaction
|
19.0%
11/58 • Number of events 11 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
General disorders
Asthenia
|
60.3%
35/58 • Number of events 42 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
General disorders
Influenza like illness
|
8.6%
5/58 • Number of events 12 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
General disorders
Pyrexia
|
25.9%
15/58 • Number of events 35 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
8.6%
5/58 • Number of events 5 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Nervous system disorders
Headache
|
10.3%
6/58 • Number of events 8 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.6%
5/58 • Number of events 5 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.6%
16/58 • Number of events 22 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.1%
7/58 • Number of events 8 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
6/58 • Number of events 10 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.7%
12/58 • Number of events 13 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
5/58 • Number of events 6 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.6%
5/58 • Number of events 5 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Nervous system disorders
Dysgeusia
|
24.1%
14/58 • Number of events 15 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Nervous system disorders
Syncope
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Psychiatric disorders
Insomnia
|
12.1%
7/58 • Number of events 7 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Psychiatric disorders
Irritability
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Renal and urinary disorders
Nocturia
|
6.9%
4/58 • Number of events 4 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.9%
4/58 • Number of events 4 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
5/58 • Number of events 6 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Vascular disorders
Hypotension
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Endocrine disorders
Hypothyroidism
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Gastrointestinal disorders
Abdominal distension
|
5.2%
3/58 • Number of events 4 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Gastrointestinal disorders
Constipation
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
7/58 • Number of events 7 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
5/58 • Number of events 5 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Gastrointestinal disorders
Dyspepsia
|
12.1%
7/58 • Number of events 9 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Renal and urinary disorders
Pollakiuria
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
Eye disorders
Lacrimation increased
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
|
General disorders
Fatigue
|
5.2%
3/58 • Number of events 3 • Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
- Publication restrictions are in place
Restriction type: OTHER