Trial Outcomes & Findings for SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women (NCT NCT01185782)

NCT ID: NCT01185782

Last Updated: 2013-12-27

Results Overview

Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 300 participants
• Primary outcome timeframe: On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]
• Results posted on: 2013-12-27

Participant Flow

Participants were recruited in 21 study centers in Japan from 15 February 2007 to 25 December 2007.

300 participants were enrolled in the study; 39 participants discontinued prior to Investigational Medicinal Product (IMP) administration (35 participants for no longer meeting the eligibility criteria 4 due to Adverse Events [AEs] or other reasons). Demographic data was not available for the 4 participants who were randomized but not treated.

Participant milestones

Measure	SJ-0021 SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Study STARTED	129	136
Overall Study Treated	129	132
Overall Study COMPLETED	123	125
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Measure	SJ-0021 SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Study Adverse Event	0	1
Overall Study Protocol Violation	1	0
Overall Study Poor Response to Treatment	3	1
Overall Study Other	2	5
Overall Study Randomized but not treated	0	4

Baseline Characteristics

SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women

Baseline characteristics by cohort

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	Total n=261 Participants Total of all reporting groups
Age, Continuous	31.6 years STANDARD_DEVIATION 3.8 • n=5 Participants	31.6 years STANDARD_DEVIATION 3.8 • n=7 Participants	31.6 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	132 Participants n=7 Participants	261 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Previous episodes of Ovarian hyperstimulation syndrome (OHSS) 0	116 participants n=5 Participants	119 participants n=7 Participants	235 participants n=5 Participants
Previous episodes of Ovarian hyperstimulation syndrome (OHSS) 1	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
Previous episodes of Ovarian hyperstimulation syndrome (OHSS) 2	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Previous episodes of Ovarian hyperstimulation syndrome (OHSS) 3	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Previous episodes of Ovarian hyperstimulation syndrome (OHSS) 4	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]

Population: Full analysis set (FAS) included all participants who received at least 1 dose of IMP and had no major violation of Good Clinical Practice (GCP) such as non-compliance with the agreement, serious protocol violations, etc.

Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.

Outcome measures

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Percentage of Participants With Ovulation	79.1 percentage of participants	82.6 percentage of participants

SECONDARY outcome

Timeframe: Start of treatment period until Day 1 of post-treatment assessment period

Population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.

Outcome measures

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter	117 participants	125 participants

SECONDARY outcome

Timeframe: Start of treatment period until Day 1 of post-treatment assessment period

Population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis.

Dosing time length was calculated as number of days from the first administration of the IMP until the mean diameter of the dominant follicle was confirmed to have reached 18 mm.

Outcome measures

Measure	SJ-0021 n=117 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=125 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Time for Dominant Follicle to Achieve 18 mm in Mean Diameter	13.1 days Standard Deviation 5.1	12.1 days Standard Deviation 4.2

SECONDARY outcome

Timeframe: Start of treatment period until Day 1 of post-treatment assessment period

Population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis of this parameter.

Total dose of IMP administered was defined as the cumulative dose administered from the start of treatment with IMP until the mean diameter of the dominant follicle reached 18 mm.

Outcome measures

Measure	SJ-0021 n=117 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=125 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter	959.29 IU Standard Deviation 533.32	845.70 IU Standard Deviation 432.88

SECONDARY outcome

Timeframe: Day 1 of post-treatment assessment period

Population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.

hCG cancellation criterion was defined as the presence of 4 or more ovarian follicles with a mean diameter greater than or equal to 16 mm. If the hCG cancellation criterion was met, the administration of hCG was withheld. Otherwise, a single intramuscular dose of hCG 5000 IU (Japanese Pharmacopoeia- JP) was administered within 24 hours of the last ultrasound examination.

Outcome measures

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Human Chorionic Gonadotropin (hCG) Cancellation Rate	7.0 percent hCG cancellation	7.6 percent hCG cancellation

SECONDARY outcome

Timeframe: Start of treatment period until Day 1 of post-treatment assessment period

Population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.

Single follicle maturation was defined as the presence of the dominant follicle with a mean diameter of 18 mm or greater without concurrent presence of other follicles of 14 mm or larger in diameter.

Outcome measures

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Single Follicle Maturation Rate	33.3 percent single follicle maturation	43.2 percent single follicle maturation

SECONDARY outcome

Timeframe: Day 28-31 of post-treatment assessment period

Population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.

Biochemical pregnancy was defined as a positive pregnancy test (urinary beta-hCG test) on Day 28-31 of the post-treatment assessment period

Outcome measures

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Biochemical Pregnancy Rate	17.8 percent biochemical pregnancy	15.2 percent biochemical pregnancy

SECONDARY outcome

Timeframe: Day 35-42 of post-treatment assessment period

Population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.

Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.

Outcome measures

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Clinical Pregnancy Rate	17.1 percent clinical pregnancy	14.4 percent clinical pregnancy

SECONDARY outcome

Timeframe: On Day 6±1 or 9±1 during post-treatment assessment period

Population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.

For this secondary endpoint, participants were considered to have ovulated if serum P4 level was more than or equal to 10 ng/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.

Outcome measures

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy	71.3 percent ovulation	75.8 percent ovulation

SECONDARY outcome

Timeframe: Pretrial observation period to post-treatment assessment period (Days 35-42)

Population: Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.

AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the IMP. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants who discontinued from the study due to AE were also recorded.

Outcome measures

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation TEAEs	69 participants	66 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation SAEs	1 participants	1 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation Discontinuation due to AEs	0 participants	1 participants

SECONDARY outcome

Timeframe: Start of treatment period to post-treatment assessment period (Day 35-42)

Population: Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.

OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.

Outcome measures

Measure	SJ-0021 n=129 Participants SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 Participants Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Number of Participants With OHSS	10 participants	5 participants

Adverse Events

SJ-0021

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

u-hFSH

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	SJ-0021 n=129 participants at risk SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 participants at risk Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	0.78% 1/129 • Number of events 1 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.	0.76% 1/132 • Number of events 1 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.

Other adverse events

Measure	SJ-0021 n=129 participants at risk SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.	u-hFSH n=132 participants at risk Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Gastrointestinal disorders Abdominal pain lower	4.7% 6/129 • Number of events 7 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.	10.6% 14/132 • Number of events 17 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.
Gastrointestinal disorders Abdominal distension	7.0% 9/129 • Number of events 10 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.	5.3% 7/132 • Number of events 7 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.
Gastrointestinal disorders Ascites	3.1% 4/129 • Number of events 4 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.	5.3% 7/132 • Number of events 7 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.
Infections and infestations Nasopharyngitis	7.8% 10/129 • Number of events 10 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.	8.3% 11/132 • Number of events 11 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.
Nervous system disorders Headache	4.7% 6/129 • Number of events 6 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.	6.1% 8/132 • Number of events 9 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	7.0% 9/129 • Number of events 9 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.	3.0% 4/132 • Number of events 4 • AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.

Additional Information

Merck KGaA Communication Center

Merck Serono Co., Ltd., Japan, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: service@merckgroup.com

Results disclosure agreements

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

Restriction type: OTHER