Here is the design of a clinical trial:

Official Title: Effect of a Systematic Preventive Versus Curative Strategy of Fluid Removal on the Weaning of Mechanical Ventilation

Included conditions:
- Respiratory Insufficiency

Study Armgroups:
- {'label': '1', 'type': 'EXPERIMENTAL', 'description': 'Preventive initiation of fluid removal', 'interventionNames': ['Other: Preventive initiation of fluid removal']}
- {'label': '2', 'type': 'OTHER', 'description': 'Curative initiation of fluid removal', 'interventionNames': ['Other: Curative initiation of fluid removal']}

Interventions:
- {'type': 'OTHER', 'name': 'Preventive initiation of fluid removal', 'description': 'Preventive initiation of fluid removal will be started right after the randomization with intravenous diuretics according to a predefined algorithm based on the urine output every three hours.\n\nThe weaning process and post extubation preventive strategy will be protocolized based on the last international guidelines', 'armGroupLabels': ['1']}
- {'type': 'OTHER', 'name': 'Curative initiation of fluid removal', 'description': 'The initiation of fluid removal will be considered by the attending physician only in case of failure to the spontaneous breathing trial with a clinical suspicion of weaning induced pulmonary edema.\n\nThe weaning process and post extubation preventive strategy will be protocolized based on the last international guidelines', 'armGroupLabels': ['2']}

Primary Outcomes:
- {'measure': 'Duration of weaning from mechanical ventilation', 'description': 'Time elapsed between the day of randomization and the day of successful extubation (patient alive without reintubation 7 days after extubation)', 'timeFrame': '28 days'}

Please estimate the sample size based on the assumption: 
Power of 90%, two-sided alpha level of 0.05, using a likelihood ratio test in a Fine & Gray model with a time interaction term.
Sample size and its statistical justification
        A statistician calculated the sample size by estimating by simulation (2000 data sets) under a Weibull distribution using the following hypotheses derived from the BMW trial11: a cumulative incidence of successful extubation of 60% by day 7 and 80% by day 28 taking into account a competitive risk of death of 13% by day 7 and 16% by day 28. We determined that the enrolment of 410 patients (205 patients per group) would provide a power of 90% to show an absolute reduction of weaning duration of 1.6âdays (4.9âdays for the curative strategy versus 3.3âdays for the preventive strategy) with a two-sided alpha level of 0.05 using a likelihood ratio test in a Fine & Gray model with a time interaction term.