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What am I missing? There were two vehicle groups!

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polenta2018

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170

05/02/21

17:06

Post #: 50748353
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Originally posted by frisbeehead: ↑

There were 22 people in each cohort of the study.

******************************************************
From the announcement:
Results of the BTX 1801 Study show the two formulations of BTX 1801 met the Study endpoints.
Firstly, BTX 1801 was safe and well tolerated, with all 66 enrolled participants successfully completing
the 1801 Study with each group (ointment, gel and vehicle) consisting of 22 participants.

At Day 7, one of the secondary endpoints (2 days after the end of the treatment period), Staph
eradication was demonstrated in 76.2% and 68.8% of the participants in the BTX 1801 ointment and
gel groups respectively, compared with 27.8% of participants in the combined vehicle groups
******************************************************

76.2% of the ointment participants equals .762 of the group. That is 17.76 people.
They say that 23.8% of the participants had eradication after 28 days. That is 5.23 people.

The 68.8% figure is for gel. That is 15.1 people
27.8% of 22 is 6.118 people

At Day 12 (7 days after the end of the treatment period), the primary endpoint, BTX 1801 demonstrated Staph
eradication in 38.1% of participants in the ointment group and 25.0% in the gel group, compared to
16.7% for the combined vehicle groups.

38.1% of 22 is 8.38 people.
25% of 22 is 5.5 people.

What are the combined vehicle groups? There's only one vehicle group.

How are these numbers possible if the figures are for eradication in participants?

If the bacteria was eradicated in 76% of the ointment group, rounded up to 18 people, why did it grow back in 12 or 13 of them, over a 3 week period?

It's likely that these anomalies are part of the reason for the poor SP response and it will be useful to get a clarification.

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What am I missing? There were two vehicle groups!

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