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Investigators are also requested to try as much as possible to re-contact those patients at the end of the trial to obtain at least their vital status as well as their status with respect to the primary endpoint, and thus avoid lost to follow-up for the efficacy assessment. If patients are lost to follow-up, the CRF must be completed up to the last visit or contact. But the new and at times elevated levels of hormones don't mean that all teenagers are horn dogs who can't keep their hands off one another. The Intent-to-Treat (ITT) population will consist of all randomized patients who take at least one dose of study drug. Occurrence of an outcome event according to the judgment of the investigator is not considered a valid reason for study drug discontinuation. If the pregnancy ends for any reason before the anticipated date, the investigator should notify the Sponsor or designee. For randomized patients who discontinued treatment with study drug, the primary reason for discontinuation will be listed and summarized by treatment group.

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