Here is the design of a clinical trial:

Official Title: Proof-of-concept Randomized Controlled Trial to Evaluate Dental Caries Preventive Effects of Fluoridated Bottled Water

Included conditions:
- Dental Caries in Children

Study Armgroups:
- {'label': 'Fluoridated bottle water', 'type': 'EXPERIMENTAL', 'description': "5-gallon bottles containing water from the New Bern Water Resources Division's Black Creek aquifer which contains naturally-occurring fluoride in a concentration of approximately 0.8 mg/L F", 'interventionNames': ['Other: Fluoridated bottled drinking water']}
- {'label': 'Non-fluoridated bottled water', 'type': 'PLACEBO_COMPARATOR', 'description': "5-gallon bottles containing water from the North Lenoir Water Corporation's Black Creek aquifer which contains a negligible concentration of fluoride.", 'interventionNames': ['Other: Non-fluoridated drinking water']}

Interventions:
- {'type': 'OTHER', 'name': 'Fluoridated bottled drinking water', 'description': 'Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.', 'armGroupLabels': ['Fluoridated bottle water']}
- {'type': 'OTHER', 'name': 'Non-fluoridated drinking water', 'description': 'Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.', 'armGroupLabels': ['Non-fluoridated bottled water']}

Primary Outcomes:
- {'measure': 'dmfs index', 'description': 'The number of primary tooth surfaces that are decayed, missing or filled will be enumerated during dental examinations of children near the time of their 4th birthday. Decay will be assessed clinically at the threshold of macroscopic enamel loss, as per criteria defined by the International Caries Detection and Assessment System. Five surfaces per tooth will be enumerated in all primary teeth (maximum = 20 teeth per child), yielding a count of affected surfaces that can range from 0 (no dental caries experience) to 100 (worst possible extent of dental caries experience). The lower-case abbreviation "dmfs" signifies disease in the primary dentition, a convention used to distinguish it from equivalent measures for the permanent dentition, where an uppercase abbreviation is used, as defined for the National Library of Medicine\'s Medical Subject Heading heading "DMF Index".', 'timeFrame': 'Dental examination in year 4'}

Please estimate the sample size based on the assumption: 
Power of 80%, 1-tailed alpha = 0.2, and a presumed loss to follow-up of 20%.
Sample size {14}
            The power calculation for this phase 2b trial is based on the principle that pilot studies should replicate, in miniature, a definitive trial that would be conducted if justified by findings from the pilot study [17]. By definition, such pilot studies lack the statistical power of a definitive trial. Instead, the goal is to calculate the point estimate of the preventive effect size and plausible range of effect size estimates to make the following three decisions:If the pilot studyâs point estimate of effect size is zero or less, and there were no significant flaws in the conduct of the pilot study, a definitive trial is contra-indicated (i.e., a null or harmful finding).If the one-tailed, upper 80% confidence limit of the pilot study effect size is less than the a priori threshold of public-health-significance, then a definitive trial is probably unjustifiable because it would require a very large sample size to estimate a meager health benefit.Otherwise, the definitive trial should go ahead using the point estimate from the pilot study as the effect size when calculating the required sample size for the definitive trial.
            When applied using estimates of the dmfs index for 3â4 year-olds living in non-fluoridated areas of the US [4], that approach yields a required sample size of 158 subjects (79 per study group), specifying a clinically significant group difference of 1.1 (s.d. = 7.8), equivalent to 37% reduction in mean dmfs, and power of 80%. (Specifically, using the SAS power procedure with options âtwo sample means ci = diff halfwidth = 1.1, stddev = 7.8,â 1-tailed alpha = 0.2 and probwidth = 0.8.) The required sample size of 158 subjects with 4-year-old dmfs data was increased to 200 randomized subjects to allow for a presumed loss to follow-up of 20% between enrollment and the 4th Birthday Dental Caries Examination.