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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03583164
Registration number
NCT03583164
Ethics application status
Date submitted
17/05/2018
Date registered
11/07/2018
Titles & IDs
Public title
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
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Scientific title
Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options
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Secondary ID [1]
0
0
F901318/0032
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Universal Trial Number (UTN)
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Trial acronym
FORMULA-OLS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Invasive Fungal Infections
0
0
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Condition category
Condition code
Infection
0
0
0
0
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Studies of infection and infectious agents
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Infection
0
0
0
0
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Other infectious diseases
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Infection
0
0
0
0
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Olorofim
Experimental: Olorofim (F901318) - Olorofim (F901318) was given orally for up to 90 days in the Main Study Phase and could be continued for those participants entering the Extended Treatment Phase.
Patients received fixed doses comprising of a 1-day loading dose of 150 mg of olorofim twice a day followed by a maintenance dose of 90 mg of olorofim twice a day.
Up until Protocol Amendment 06, 58 patients received a weight-based olorofim dosing consisting of a 1-day loading dose of 4 mg/kg/day on Day 1, then a maintenance dose of 2.5 mg/kg/day (divided into 2 or 3 doses). The dose was then adjusted based on plasma levels of olorofim with the maximum total daily dose of 300 mg.
Treatment: Drugs: Olorofim
30mg oral tablets
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Data Review Committee (DRC) Adjudicated Overall Response at Day 42
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Assessment method [1]
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The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. For the primary statistical analysis of overall response rate, values were assigned to the DRC adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Day 42 Study Visit could not be collected or participants who were considered not evaluable at the Day 42 Study Visit).
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Timepoint [1]
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Day 42 in the Main Phase of study treatment
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Secondary outcome [1]
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DRC Adjudicated Overall Response at Day 42 for All Aspergillus
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Assessment method [1]
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The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline. The Aspergillus- All category is a combination of participants with Aspergillus proven and Aspergillus probable (invasive aspergillosis lower respiratory tract disease) baseline disease category. Overall success is defined as a Complete or Partial Response.
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Timepoint [1]
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Day 42 in the Main Phase of study treatment
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Secondary outcome [2]
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DRC Adjudicated Overall Response at Day 42 for Lomentospora Prolificans
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Assessment method [2]
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The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent Data Review Committee using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Lomentospora prolificans. Success is defined as a Complete or Partial Response.
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Timepoint [2]
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Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment
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Secondary outcome [3]
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DRC Adjudicated Overall Response at Day 42 for for Scedosporium Species
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Assessment method [3]
0
0
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Scedosporium species. Success is defined as a Complete or Partial Response.
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Timepoint [3]
0
0
Day 42 in the Main Phase of study treatment
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Secondary outcome [4]
0
0
DRC Adjudicated Overall Response at Day 42 for Coccidioides Species
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Assessment method [4]
0
0
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to Coccidioides species. Success is defined as a Complete or Partial Response.
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Timepoint [4]
0
0
Day 42 in the Main Phase of study treatment
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Secondary outcome [5]
0
0
DRC Adjudicated Overall Response at Day 42 for Other Olorofim Susceptible Fungi
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Assessment method [5]
0
0
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to other olorofim susceptible fungi. Success is defined as a Complete or Partial Response.
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Timepoint [5]
0
0
Day 42 in the Main Phase of study treatment
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Secondary outcome [6]
0
0
DRC Adjudicated Overall Response at Day 84
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Assessment method [6]
0
0
DRC-adjudicated overall response at Day 84, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on the EORTC/MSG criteria. For the analysis of overall response rate, values were assigned to the DRC-adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Study Visit could not be collected or participants who were considered not evaluable at the Study Visit).
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Timepoint [6]
0
0
Day 84 in the Main Phase of study treatment
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Secondary outcome [7]
0
0
Investigator Assessed Overall Response at Day 42
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Assessment method [7]
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Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 42, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 42 could not be collected or who were considered not evaluable at the specific visit).
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Timepoint [7]
0
0
Day 42 in the Main Phase of study treatment
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Secondary outcome [8]
0
0
Investigator Assessed Overall Response at Day 84
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Assessment method [8]
0
0
Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 84, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 84 could not be collected or who were considered not evaluable at the specific visit).
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Timepoint [8]
0
0
Day 84 in the Main Phase of study treatment
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Secondary outcome [9]
0
0
DRC Adjudicated Clinical Response at Day 42
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Assessment method [9]
0
0
DRC adjudicated clinical response at the Day 42 Study Visit, as determined by an independent Data Review Committee using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
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Timepoint [9]
0
0
Day 42 in the Main phase of study treatment
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Secondary outcome [10]
0
0
DRC Adjudicated Clinical Response at Day 84
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Assessment method [10]
0
0
DRC adjudicated clinical response at the Day 84 Study Visit, as determined by an independent DRC using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
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Timepoint [10]
0
0
Day 84 in the Main phase of study treatment
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Secondary outcome [11]
0
0
Investigator Assessed Clinical Response at Day 42
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Assessment method [11]
0
0
Investigator assessed clinical response at the Day 42 Study Visit using clinical response results based on the EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
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Timepoint [11]
0
0
Day 42 in the Main phase of study treatment
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Secondary outcome [12]
0
0
Investigator Assessed Clinical Response at Day 84
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Assessment method [12]
0
0
Investigator assessed clinical response at the Day 84 Study Visit using clinical response results based on the EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
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Timepoint [12]
0
0
Day 84 in the Main Phase of study treatment
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Secondary outcome [13]
0
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DRC Adjudicated Mycological Response at Day 42
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Assessment method [13]
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DRC adjudicated mycological response was assessed at the Day 42 Study Visit, as determined by an independent Data Review Committee using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
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Timepoint [13]
0
0
Day 42 in the Main Phase of study treatment
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Secondary outcome [14]
0
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DRC Adjudicated Mycological Response at Day 84
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Assessment method [14]
0
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DRC adjudicated mycological response was assessed at the Day 84 Study Visit, as determined by an independent DRC using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
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Timepoint [14]
0
0
Day 84 in the Main phase of study treatment
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Secondary outcome [15]
0
0
Investigator Assessed Mycological Response at Day 42
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Assessment method [15]
0
0
Mycological response was assessed by the Investigator at the Day 42 Study Visit using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
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Timepoint [15]
0
0
Day 42 in the Main Phase of study treatment
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Secondary outcome [16]
0
0
Investigator Assessed Mycological Response at Day 84
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Assessment method [16]
0
0
Mycological response was assessed by the Investigator at the Day 84 Study Visit using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
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Timepoint [16]
0
0
Day 84 in the Main Phase of study treatment
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Secondary outcome [17]
0
0
DRC Adjudicated Radiological Response at Day 42
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Assessment method [17]
0
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In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 42 and were adjudicated by an independent DRC. Radiological responses were assigned as per EORTC/MSG criteria.
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Timepoint [17]
0
0
Day 42 in the Main phase of study treatment
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Secondary outcome [18]
0
0
DRC Adjudicated Radiological Response at Day 84
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Assessment method [18]
0
0
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 84 and were adjudicated by an independent DRC. Radiological responses were assigned as per EORTC/MSG criteria.
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Timepoint [18]
0
0
Day 84 in the Main Phase of study treatment
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Secondary outcome [19]
0
0
Investigator Assessed Radiological Response at Day 42
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Assessment method [19]
0
0
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 42. Radiological responses were assessed by the Investigator using EORTC/MSG criteria.
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Timepoint [19]
0
0
Day 42 in the Main Phase of study treatment
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Secondary outcome [20]
0
0
Investigator Assessed Radiological Response at Day 84
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Assessment method [20]
0
0
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 84. Radiological responses were assessed by the Investigator using EORTC/MSG criteria.
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Timepoint [20]
0
0
Day 84 in the Main Phase of study treatment
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Secondary outcome [21]
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All Cause Mortality Rate at Day 42
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Assessment method [21]
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The all cause mortality rate at Day 42 uses the survival status that was entered at the study visit (which employs a window around each nominal study day).
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Timepoint [21]
0
0
Day 42 in the Main Phase of study treatment
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Secondary outcome [22]
0
0
All Cause Mortality Rate at Day 84
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Assessment method [22]
0
0
The all cause mortality rate at Day 84 uses the survival status that was entered at the study visit (which employs a window around each nominal study day).
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Timepoint [22]
0
0
Day 84 in the Main Phase of study treatment
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Eligibility
Key inclusion criteria
* Male and female aged at least 18 years, or male and female aged 16 years or 17 years and who weigh at least 40 kg whom have given informed consent
* Ability and willingness to comply with the protocol.
* Able to take oral medication
* Females must be non-lactating and at no risk of pregnancy
* Male with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception
* Participants with invasive fungal disease
* Participants who have limited alternative treatment options
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Women who are pregnant or breastfeeding.
* Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
* Participants with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis.
* Human Immunodeficiency Virus (HIV) infection but not currently receiving antiretroviral therapy.
* Participants with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the participant
* Previously enrolled participants or participants enrolled in any clinical trial within the last 30 days
* Participants receiving treatment limited to supportive care due to predicted short survival time.
* Prohibited concomitant medications.
* Any exclusion criteria required by local regulatory authorities.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/02/2023
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Sample size
Target
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Accrual to date
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Final
203
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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0
Westmead Hospital - Westmead
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [3]
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0
Peter MacCallum Centre-East Melbourne - Melbourne
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Recruitment hospital [4]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [5]
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The Alfred Hospital - Melbourne
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Recruitment hospital [6]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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0
2145 - Westmead
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Georgia
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Illinois
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Maryland
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Massachusetts
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Missouri
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Country [7]
0
0
United States of America
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State/province [7]
0
0
New York
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Country [8]
0
0
United States of America
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State/province [8]
0
0
North Carolina
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Pennsylvania
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Texas
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Waals-Brabant
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Country [12]
0
0
Belgium
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State/province [12]
0
0
Brussels
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Country [13]
0
0
Belgium
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State/province [13]
0
0
Bruxelles
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Country [14]
0
0
Brazil
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State/province [14]
0
0
Minas Gerais
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Paraná
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Country [16]
0
0
Brazil
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State/province [16]
0
0
Rio Grande Do Sul
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Country [17]
0
0
Brazil
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State/province [17]
0
0
Curitiba
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Country [18]
0
0
Brazil
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State/province [18]
0
0
Passos
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Country [19]
0
0
Egypt
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State/province [19]
0
0
Alexandria
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Country [20]
0
0
Egypt
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State/province [20]
0
0
Cairo
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Country [21]
0
0
Egypt
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State/province [21]
0
0
Mansoura
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Country [22]
0
0
France
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State/province [22]
0
0
Bas Rhin
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Country [23]
0
0
France
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State/province [23]
0
0
Isere
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Country [24]
0
0
France
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State/province [24]
0
0
Paris
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Country [25]
0
0
France
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State/province [25]
0
0
Paris cedex 10
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Country [26]
0
0
Germany
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State/province [26]
0
0
Bayern
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Country [27]
0
0
Germany
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State/province [27]
0
0
Nordrhein Westfalen
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Country [28]
0
0
Germany
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State/province [28]
0
0
Berlin
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0
0
Israel
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State/province [29]
0
0
Beer-Sheva
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0
0
Israel
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State/province [30]
0
0
Haifa
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Country [31]
0
0
Israel
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State/province [31]
0
0
Jerusalem
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Country [32]
0
0
Israel
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State/province [32]
0
0
Ramat Gan
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Country [33]
0
0
Israel
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State/province [33]
0
0
Tel Aviv
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Country [34]
0
0
Korea, Republic of
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State/province [34]
0
0
Seoul
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Country [35]
0
0
Netherlands
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State/province [35]
0
0
Nijmegen
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0
0
Netherlands
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State/province [36]
0
0
Rotterdam
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Country [37]
0
0
Netherlands
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State/province [37]
0
0
Utrecht
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Country [38]
0
0
Poland
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State/province [38]
0
0
Gdansk
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0
0
Poland
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State/province [39]
0
0
Krakow
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0
0
Poland
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State/province [40]
0
0
Slupsk
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0
0
Poland
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State/province [41]
0
0
Warszawa
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Country [42]
0
0
Russian Federation
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State/province [42]
0
0
Saint Petersburg
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Country [43]
0
0
Spain
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State/province [43]
0
0
Barcelona
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Country [44]
0
0
Spain
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State/province [44]
0
0
Madrid
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Country [45]
0
0
Spain
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State/province [45]
0
0
Valencia
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Country [46]
0
0
Thailand
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State/province [46]
0
0
Bangkok
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Country [47]
0
0
Turkey
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State/province [47]
0
0
Diyarbakir
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Country [48]
0
0
Turkey
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State/province [48]
0
0
Istanbul
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Country [49]
0
0
United Kingdom
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State/province [49]
0
0
Greater London
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Country [50]
0
0
United Kingdom
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State/province [50]
0
0
Greater Manchester
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Country [51]
0
0
United Kingdom
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State/province [51]
0
0
Wythenshawe
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Country [52]
0
0
Vietnam
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State/province [52]
0
0
Hanoi
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Country [53]
0
0
Vietnam
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State/province [53]
0
0
Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
F2G Biotech GmbH
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Iqvia Pty Ltd
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
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Trial website
https://clinicaltrials.gov/study/NCT03583164
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Sharon Chen
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Address
0
0
Westmead Hospital
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Daniea Zinzi
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Address
0
0
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Country
0
0
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Phone
0
0
43 664 3582281
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Individual participant data that underlie the results can be available to researchers after the primary publication of results for this study, after deidentification (text, tables, figures, appendices)
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
From 3 months after publication of the primary manuscript (no end date)
Query!
Available to whom?
Requests should be directed to F2G for review.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/64/NCT03583164/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/64/NCT03583164/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03583164