Trial Outcomes & Findings for A Study of Adavosertib (MK-1775) in Combination With Topotecan/Cisplatin in Participants With Cervical Cancer (MK-1775-008) (NCT NCT01076400)

Last Updated: 2023-09-18

Results Overview

On the basis of Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, PR is at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. CR is the disappearance of all extranodal target lesions, where all pathological lymph nodes must have decreased to \<10 mm in the short axis.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to approximately 1 year

Results posted on

2023-09-18

Participant Flow

Due to the early termination of the study by the sponsor, no participants were enrolled in Part 2 of the study.

Participant milestones

Participant milestones
Measure	Part 1: MK-1775 + Topotecan/Cisplatin Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.	Part 2: MK-1775 + Topotecan/Cisplatin Part 2: MK-1775 capsules will be administered at the dose determined in Part 1 twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1.	Part 2: Placebo to MK-1775 + Topotecan/Cisplatin Part 2: Placebo to MK-1775 capsules will be administered twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1.
Overall Study STARTED	7	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	7	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: MK-1775 + Topotecan/Cisplatin Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.	Part 2: MK-1775 + Topotecan/Cisplatin Part 2: MK-1775 capsules will be administered at the dose determined in Part 1 twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1.	Part 2: Placebo to MK-1775 + Topotecan/Cisplatin Part 2: Placebo to MK-1775 capsules will be administered twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1.
Overall Study Adverse Event	2	0	0
Overall Study Progressive Disease	5	0	0

Baseline Characteristics

A Study of Adavosertib (MK-1775) in Combination With Topotecan/Cisplatin in Participants With Cervical Cancer (MK-1775-008)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: MK-1775 + Topotecan/Cisplatin n=7 Participants Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
Age, Continuous	50.3 Years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 1 year

Population: The study was prematurely terminated, and data were not collected, so no analyses were performed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to approximately 1 year

Population: Participants who completed the first cycle of combination therapy or discontinued from the study due to a DLT attributable to study therapy. One participant who violated the protocol was not assessed for DLTs.

A DLT is a protocol-defined, (hematologic and non-hematologic), AE that must be definitely, probably, or possibly related to the study therapy. A DLT is any of the following: Grade 4-5 hematological toxicity; Grade 3 or Grade 4 neutropenia with fever \>38.°C and/or infection requiring antibiotic or anti-fungal treatment. Non-hematologic dose-limiting toxicities are any Grade 3, 4, or 5 non-hematologic toxicity, with specific exceptions. If occurring within the first cycle of combination therapy: unresolved drug-related toxicity, preventing (re) treatment for 3 weeks or more from the date of the next scheduled treatment or any drug-related toxicity preventing the participant from taking at least 75% of the doses of MK-1775 with each administration of chemotherapy.

Outcome measures

Outcome measures
Measure	Part 1: MK-1775 + Topotecan/Cisplatin n=6 Participants Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)	2 Number of participants

PRIMARY outcome

Timeframe: Up to approximately 1 year

Population: Due to the early termination of the study Part 2 was not performed.

PFS is the length of time during and after treatment that a participant lives, but whose tumor progression does not worsen. PFS is defined as the time from randomization to progressive disease or death, whichever occurs earlier. Tumor volume changes of +20% for progressive disease was used to be consistent with RECIST 1.1.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: MK-1775 + Topotecan/Cisplatin

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: MK-1775 + Topotecan/Cisplatin n=7 participants at risk Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
Blood and lymphatic system disorders Febrile neutropenia	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Infections and infestations Escherichia bacteraemia	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Urinary tract obstruction	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	Part 1: MK-1775 + Topotecan/Cisplatin n=7 participants at risk Part 1: MK-1775 capsules were administered at 50 mg twice daily on Days 1-4, and once on Day 5 for a total of nine doses per cycle. Each cycle was 21 days. Topotecan was administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 of each cycle. Cisplatin was administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1 of each cycle. Only a single dose of MK-1775 was administered during Part 1.
Blood and lymphatic system disorders Anaemia	85.7% 6/7 • Number of events 17 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	85.7% 6/7 • Number of events 18 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	71.4% 5/7 • Number of events 19 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Ear and labyrinth disorders Ear pain	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Ear and labyrinth disorders Tinnitus	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Ear and labyrinth disorders Vertigo	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	42.9% 3/7 • Number of events 3 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	57.1% 4/7 • Number of events 7 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	57.1% 4/7 • Number of events 5 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Dyspepsia	28.6% 2/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Flatulence	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	57.1% 4/7 • Number of events 9 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	42.9% 3/7 • Number of events 10 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
General disorders Asthenia	57.1% 4/7 • Number of events 7 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
General disorders Chest pain	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
General disorders Discomfort	14.3% 1/7 • Number of events 3 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
General disorders Fatigue	28.6% 2/7 • Number of events 5 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
General disorders Influenza like illness	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
General disorders Mucosal inflammation	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
General disorders Oedema peripheral	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
General disorders Pyrexia	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Infections and infestations Cystitis	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Infections and infestations Device related infection	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Infections and infestations Hordeolum	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Infections and infestations Infection	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Infections and infestations Oral candidiasis	14.3% 1/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Infections and infestations Rhinitis	14.3% 1/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Infections and infestations Skin infection	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Ligament sprain	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Blood alkaline phosphatase increased	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Blood creatinine increased	14.3% 1/7 • Number of events 5 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Blood magnesium decreased	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Blood sodium decreased	14.3% 1/7 • Number of events 4 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Haemoglobin decreased	14.3% 1/7 • Number of events 4 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Neutrophil count decreased	28.6% 2/7 • Number of events 3 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Platelet count decreased	14.3% 1/7 • Number of events 3 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations Weight decreased	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Investigations White blood cell count decreased	28.6% 2/7 • Number of events 5 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	28.6% 2/7 • Number of events 3 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Dehydration	14.3% 1/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	28.6% 2/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	28.6% 2/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Hypercreatinaemia	14.3% 1/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	14.3% 1/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Nervous system disorders Dysgeusia	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Nervous system disorders Headache	71.4% 5/7 • Number of events 6 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Nervous system disorders Lethargy	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Nervous system disorders Neuropathy peripheral	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Psychiatric disorders Anxiety	28.6% 2/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Psychiatric disorders Depression	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Dysuria	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Hydronephrosis	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Pollakiuria	14.3% 1/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Urinary incontinence	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	28.6% 2/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	28.6% 2/7 • Number of events 3 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Vascular disorders Deep vein thrombosis	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Vascular disorders Hot flush	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Vascular disorders Hypertension	14.3% 1/7 • Number of events 2 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.
Vascular disorders Pelvic venous thrombosis	14.3% 1/7 • Number of events 1 • At least 30 days following last dose of study therapy or until death (up to approximately 1 year). All randomized participants who received at least one dose of study treatment.

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 SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER