You will be shown the abstract of a medical clinical trial report. Your task is to extract all the findings from this report into a JSON array. Each finding should contain the following five elements:

- Intervention: The medical intervention being tested. This should be a text span copied from the input passage.
- Comparator: The baseline against which the intervention is being evaluated. This should be a text span copied from the input passage. If no comparator is reported, set to `null`.
- Outcome: The medical outcome whose effect is being measured. This should be a text span copied from the input passage.
- Effect: The effect of the intervention on the outcome, relative to the comparator. The effect should be one of the following three values: ("significantly increased", "significantly decreased", "no significant difference").
- Evidence: The evidence for the effect. This should be a text span copied from the input passage.

Please format your output as a JSON array. Each entry in the output should be an array containing the 5 elements listed above, in the following order: [<intervention>, <comparator>, <outcome>, <effect>, <evidence>].

For example, an output with two findings might read:
```
[["aspirin", "placebo", "headache severity", "significantly decreased", "Mean headache severity was significantly decreased in the aspirin group compared to the placebo group (p < 0.05)."], ["aspirin", "placebo", "weight loss", "no significant difference", "We did not observe any difference in weight loss between the group given aspirin relative to the control group"]]
```

There are 2 finding(s) in the abstract below. Please extract them. Output only the JSON array with these 2 findings. Do not include any additional text.

Abstract:
ABSTRACT.BACKGROUND/AIMS:: Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc).

ABSTRACT.METHODS:: This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial's sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure.

ABSTRACT.RESULTS:: We included 142 of 231 protocols in the final analysis (concept = 78; ad hoc = 64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval = 0.10–0.58)) than in the concept arm (0.27 (0.06–0.50)), but the difference was not significant (p = 0.67).

ABSTRACT.LIMITATIONS:: The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law.

ABSTRACT.CONCLUSION:: A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines, examples and templates to ensure correct application.

Findings:
[["New law criteria (Concept)", "Intuitive approach (ad hoc)", "Agreement between Experts and Sponsors", "no significant difference", "Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval = 0.10\u20130.58)) than in the concept arm (0.27 (0.06\u20130.50)), but the difference was not significant (p = 0.67)."], ["New law criteria (Concept)", "Intuitive approach (ad hoc)", "Kappa values", "no significant difference", "Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval = 0.10\u20130.58)) than in the concept arm (0.27 (0.06\u20130.50)), but the difference was not significant (p = 0.67)."]]