Here is the design of a clinical trial:

Official Title: The Impact of High Versus Standard Enteral Protein Provision on Functional Recovery Following Intensive Care Admission: a Randomized Controlled, Multicenter, Parallel Group Trial in Mechanically Ventilated, Critically Ill Patients

Included conditions:
- Critical Illness
- Intensive Care Unit Acquired Weakness

Study Armgroups:
- {'label': 'PRECISe protocol EN (8g protein/100kcal)', 'type': 'EXPERIMENTAL', 'description': 'Enteral (EN) feed with 8 grams protein per 100 kcal (2.0 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission.', 'interventionNames': ['Dietary Supplement: PRECISe protocol EN 8g protein/100kcal']}
- {'label': 'PRECISe protocol EN (5g protein/100kcal)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Enteral (EN) feed with 5 grams protein per 100 kcal (1.3 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission.', 'interventionNames': ['Dietary Supplement: PRECISe protocol EN 5g protein/100kcal']}

Interventions:
- {'type': 'DIETARY_SUPPLEMENT', 'name': 'PRECISe protocol EN 8g protein/100kcal', 'description': 'Enteral feed containing 8g protein/100kcal', 'armGroupLabels': ['PRECISe protocol EN (8g protein/100kcal)']}
- {'type': 'DIETARY_SUPPLEMENT', 'name': 'PRECISe protocol EN 5g protein/100kcal', 'description': 'Enteral feed containing 5g protein/100kcal', 'armGroupLabels': ['PRECISe protocol EN (5g protein/100kcal)']}

Primary Outcomes:
- {'measure': 'Health Related Quality of Life (HRQL)', 'description': 'Overall difference in EQ-5D single summary index between intervention and control group over the three time-points combined, corrected for baseline. A higher summary index indicates better Health related Quality of Life.', 'timeFrame': 'Day 0, Day 30, 90 and 180 after index ICU admission.'}

Please estimate the sample size based on the assumption: 
Estimated standard deviation of 0.3, type I error rate α = 0.05, type II error rate β = 0.20 (80% power), and an estimated 5% loss to follow-up. Adjusted for observed standard deviation of 0.38 and 9.4% loss to follow-up.
Sample size {14}
        Trial data of health-related quality of life scores repeated at multiple time points after ICU discharge are not readily available. For this reason, the power calculation was based on a published point-measurement of the EQ-5D-5L health utility score at 180Â days following ICU admission [46]. Reported instrument-defined minimally important difference estimates for the EQ-5D-5L utility scores are between 0.037 and 0.069 for Canada, China, Spain, Japan, England, and Uruguay scoring algorithms [47, 48]. We chose a minimum difference of 0.06 points on the EQ-5D-5L health utility score as representing the minimum clinically important difference to be detected [47].
        Based on these data, the sample size for the PRECISe trial was calculated as follows: with an estimated standard deviation (SD) of health utility scores of 0.3 at 180Â days [46], considering a type I error rate Î±â=â0.05 and a type II error rate Î²â=â0.20 (yielding a statistical power of 80%), 392 participants per intervention group will be required to detect the minimum clinically important difference of 0.06 in EQ-5D-5L health utility score. In line with other critical care trials, the sample size has been adjusted upwards for an estimated 5% loss to follow-up for the primary endpoint [19]. After this adjustment, the final sample size for the PRECISe trial was set at 824 participants.
        During the preplanned interim safety analysis, it became apparent that mortality was higher than anticipated, resulting in a standard deviation of the EQ-5D-5L HUS that was larger than expected (0.38 vs 0.30). Since this potentially could reduce the power of the study, the DSMB advised to review the statistical analysis plan to account for this and agreed on increasing sample size. By running a computer simulation of the primary outcome analysis using actual pooled data of the actual study population at that time (nâ=â709), it was calculated that with the observed standard deviation, a sample size of 935 patients would be required to retain 80% power to detect the minimally important difference of 0.06, while correcting for the actually observed loss-to-follow-up of 9.4%.