Here is the design of a clinical trial:

Official Title: Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents To Reduce Malaria Incidence In Military Personnel On Active Duty In Regions Of Hyperendemicity

Included conditions:
- Malaria

Study Armgroups:
- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'placebo group receiving untreated army combat uniform and placebo lotion. Assigned interventions: Placebo lotion - a liposome lotion with no DEET Army combat uniform - army combat uniform with no permethrin', 'interventionNames': ['Other: Placebo lotion', 'Other: Army combat uniform']}
- {'label': 'Combo', 'type': 'ACTIVE_COMPARATOR', 'description': 'Combined intervention group of receiving Permethrin treated uniform 0.52% w/w and 30% DEET liposome formula.\n\nUltra 30 Insect Repellent Lotion (30% Lipo DEET) One application of Lipo DEET protects for up to 12 hours. DEET is a broad spectrum insect repellent that has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors.\n\nPermethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft Permethrin is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings.', 'interventionNames': ['Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET)', 'Other: Permethrin Factory-Treated Army Combat Uniforms']}
- {'label': 'Permethrin', 'type': 'ACTIVE_COMPARATOR', 'description': 'permethrin intervention group receiving Permethrin treated uniform 0.52% w/w and placebo lotion.\n\nPermethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft\n\nPlacebo lotion: liposome lotion with no DEET', 'interventionNames': ['Other: Permethrin Factory-Treated Army Combat Uniforms', 'Other: Placebo lotion']}
- {'label': 'DEET', 'type': 'ACTIVE_COMPARATOR', 'description': 'DEET intervention group receiving untreated army combat uniform and 30% DEET liposome formula.\n\nUltra 30 Insect Repellent Lotion (30% Lipo DEET) Army combat uniform with no permethrin', 'interventionNames': ['Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET)', 'Other: Army combat uniform']}

Interventions:
- {'type': 'OTHER', 'name': 'Ultra 30 Insect Repellent Lotion (30% Lipo DEET)', 'description': 'One application of Lipo DEET protects for up to 12 hours and has a pleasant odour and non-greasy "feel" on the skin. DEET is a broad spectrum insect repellent and was selected this study because it has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors. DEET was first registered in 1957 and has been conclusively proven to be safe for use on adults, children, pregnant and lactating mothers.\n\nThis Liposome-based repellent is the newest advancement in insect repellent technology. The Liposome envelops the active ingredient, DEET, and slowly time-releases it as needed, thereby extending the effectiveness of the repellent and reducing dermal absorption.', 'armGroupLabels': ['Combo', 'DEET']}
- {'type': 'OTHER', 'name': 'Permethrin Factory-Treated Army Combat Uniforms', 'description': "Permethrin is the U.S., Australian and United Kingdom (UK) military's standard repellent for application to fabric and is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings; an objective easily met through factory treatment of uniforms, which demonstrates 99-100% bite protection up to 50 launderings (the expected lifetime of the uniform).", 'armGroupLabels': ['Combo', 'Permethrin']}
- {'type': 'OTHER', 'name': 'Placebo lotion', 'description': 'A liposome lotion with no DEET', 'armGroupLabels': ['Permethrin', 'Placebo']}
- {'type': 'OTHER', 'name': 'Army combat uniform', 'description': 'Army combat uniform with no permethrin', 'armGroupLabels': ['DEET', 'Placebo']}

Primary Outcomes:
- {'measure': 'Incidence of Plasmodium falciparum malaria through monthly measurement of malaria positivity by direct polymerase chain reaction (PCR) to detect parasite DNA', 'description': 'Blood spots will be collected on Whatman 3 filter paper and processed for PCR detection of parasites', 'timeFrame': 'Monthly active case detection for 12 months'}

Please estimate the sample size based on the assumption: 
The sample size was estimated using a simulation of 1000 trials with generalized linear mixed effects models. We assumed a Poisson distribution for the incidence of malaria infections and a lognormal distribution of the combania cluster effects. With 12 clusters each of 40 recruits and 12 months of follow-up, we would have 89% power to detect this difference as significant and estimate the IRR with a confidence interval of 0.49 to 0.88.
Sample size {14}
          The sample size calculations are based on the comparison of the incidence of malaria infection between the trial arms. The primary comparison is between ETU + DEET and PTU + DEET. An expected total of 1500 recruits per year form combania with a mean of 40 recruits each. We expect roughly 37 combania available for randomisation. A combania is a military subsection of recruits who carry out all activities together and sleep in the same dormitory. The dormitories can accommodate 30 to 50 recruits. The trial is randomised by combania because of the risk of contamination between recruits in the same company if the trial were individually randomised and because it is expected that a whole company will use the same interventions in practice in a âreal worldâ use scenario.
          The outcome is the incidence of malaria infection determined by PCR every 2âweeks. As a baseline estimate (with neither treated uniform nor repellent), the most recent available incidence of malaria infection in Mgambo camp among recruits is 0.68 per person per year in 2015 [40].
          The sample size was estimated using a simulation of 1000 trials using generalized linear mixed effects models written in R statistical software version to estimate the power and the precision of the estimated incidence rate ratio (IRR) (the precision is measured here by the expected width of the confidence interval). We assumed a Poisson distribution for the incidence of malaria infections among recruits and a lognormal distribution of the combania cluster effects.
          An assumed efficacy of 50% for PTU + DEET with a compliance of 80% would lead to an incidence rate of 0.41 infections per person per year. An assumed efficacy of 70% for ETU + DEET and compliance of 80% would lead to an incidence rate of 0.27 and an IRR of 0.66. With 12 clusters each of 40 recruits and 12âmonths of follow-up, we would have 89% power to detect this difference as significant and be able to estimate the IRR with a confidence interval of 0.49 to 0.88. After exploring different scenarios for unequal cluster randomisation to maximise power, we will randomise 12 combania (about 480 participants) for each arm of the primary comparison (PTU + DEET vs. ETU + DEET) and 6 combania (about 240 participants) to each of PTU + placebo lotion and untreated uniform + placebo lotion.