Trial Outcomes & Findings for Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer Risk (NCT NCT04570956)

Last Updated: 2026-09-01

Results Overview

All patients received an oral pill and a topical gel. Prior to assessing non-inferiority of 4-OHT Gel compared to Oral Tamoxifen, treatment effect was assessed within each group by testing for a significant reduction in median lobular Ki67 between PreTam and OnTam biopsy. Median lobular Ki67 is assessed using the percentage of cells stained across all lobules separately at PreTam and OnTam timepoints, evaluated for a difference in median calculated change.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

Pre-biopsy to post-biopsy following 4 weeks of intervention

Results posted on

2026-09-01

Participant Flow

Sixty-five participants were initially enrolled. One participant was a screen failure, and three withdrew from study prior to beginning the intervention.

Participant milestones

Participant milestones
Measure	Oral Tamoxifen 10 mg/Day Oral Tamoxifen 10 mg/day + gel placebo	Topical 4-OHT (4-hydroxytamoxifen) Gel 4 mg/Each Breast/Day Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day + oral placebo	Control Dual placebo (oral tamoxifen and topical 4-OHT gel)
Overall Study STARTED	25	24	12
Overall Study COMPLETED	25	23	11
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Tamoxifen 10 mg/Day Oral Tamoxifen 10 mg/day + gel placebo	Topical 4-OHT (4-hydroxytamoxifen) Gel 4 mg/Each Breast/Day Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day + oral placebo	Control Dual placebo (oral tamoxifen and topical 4-OHT gel)
Overall Study Withdrawal by Subject	0	1	1

Baseline Characteristics

Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Tamoxifen 10 mg/Day n=25 Participants Participants receive oral Tamoxifen 10 mg/day	Topical 4-OHT Gel 4 mg/Each Breast/Day n=24 Participants Participants receive topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day + oral placebo	Control n=12 Participants Participants receive placebo pill or placebo gel	Total n=61 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants	0 Participants n=49 Participants
Age, Customized 18 - 21 years	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants	0 Participants n=49 Participants
Age, Customized 22 - 29 years	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants	0 Participants n=49 Participants
Age, Customized 30 - 39 years	1 Participants n=14 Participants	0 Participants n=36 Participants	1 Participants n=324 Participants	2 Participants n=49 Participants
Age, Customized 40 - 49 years	6 Participants n=14 Participants	8 Participants n=36 Participants	4 Participants n=324 Participants	18 Participants n=49 Participants
Age, Customized 50 - 59 years	9 Participants n=14 Participants	10 Participants n=36 Participants	5 Participants n=324 Participants	24 Participants n=49 Participants
Age, Customized 60 - 69 years	6 Participants n=14 Participants	3 Participants n=36 Participants	2 Participants n=324 Participants	11 Participants n=49 Participants
Age, Customized 70 - 79 years	3 Participants n=14 Participants	3 Participants n=36 Participants	0 Participants n=324 Participants	6 Participants n=49 Participants
Sex: Female, Male Female	25 Participants n=14 Participants	24 Participants n=36 Participants	12 Participants n=324 Participants	61 Participants n=49 Participants
Sex: Female, Male Male	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants	0 Participants n=49 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=14 Participants	3 Participants n=36 Participants	2 Participants n=324 Participants	6 Participants n=49 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=14 Participants	21 Participants n=36 Participants	8 Participants n=324 Participants	51 Participants n=49 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=14 Participants	0 Participants n=36 Participants	2 Participants n=324 Participants	4 Participants n=49 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants	0 Participants n=49 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants	0 Participants n=36 Participants	1 Participants n=324 Participants	1 Participants n=49 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants	0 Participants n=49 Participants
Race (NIH/OMB) Black or African American	2 Participants n=14 Participants	1 Participants n=36 Participants	0 Participants n=324 Participants	3 Participants n=49 Participants
Race (NIH/OMB) White	23 Participants n=14 Participants	20 Participants n=36 Participants	9 Participants n=324 Participants	52 Participants n=49 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants	0 Participants n=49 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	3 Participants n=36 Participants	2 Participants n=324 Participants	5 Participants n=49 Participants
Region of Enrollment United States	25 participants n=14 Participants	24 participants n=36 Participants	12 participants n=324 Participants	61 participants n=49 Participants

PRIMARY outcome

Timeframe: Pre-biopsy to post-biopsy following 4 weeks of intervention

Population: Of the 61 patients who initiated study intervention, two withdrew during intervention and one tested positive for COVID (unable to complete the post-treatment research core biopsy). Among the remaining 58 subjects, 48 had breast tissue successfully obtained at both the pre-treatment and post-treatment timepoints for the primary endpoint. Of these 48 patients, only 42 had sufficient breast lobules seen histologically for evaluation of the primary endpoint (change in median lobular Ki67).

Outcome measures

Outcome measures
Measure	Oral Tamoxifen 10 mg/Day n=17 Participants Oral Tamoxifen 10 mg/day + gel placebo	Topical 4-OHT (4-hydroxytamoxifen) Gel 4 mg/Each Breast/Day n=18 Participants Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day \+ oral placebo	Control n=7 Participants Dual placebo (oral tamoxifen and topical 4-OHT gel)
Change in Median Lobular Ki67 From Pre-Tamoxifen Breast Biopsy to On-Tamoxifen Biopsy With 4 Weeks of Intervention	0.125 change in median percent Ki67 Interval 0.0 to 0.56	0.287 change in median percent Ki67 Interval -0.071 to 1.1019	-0.420 change in median percent Ki67 Interval -0.78 to 0.035

Adverse Events

Oral Tamoxifen 10 mg/Day

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Topical 4-OHT (4-hydroxytamoxifen) Gel 4 mg/Each Breast/Day

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Amy C. Degnim, MD

Mayo Clinic

Phone: 507-284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Oral Tamoxifen 10 mg/Day n=25 participants at risk Oral Tamoxifen 10 mg/day	Topical 4-OHT (4-hydroxytamoxifen) Gel 4 mg/Each Breast/Day n=24 participants at risk Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day +oral placebo	Control n=12 participants at risk Placebo pill or placebo gel
Psychiatric disorders Anxiety	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Psychiatric disorders Insomnia	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	4.2% 1/24 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Psychiatric disorders Irritability	12.0% 3/25 • Number of events 3 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 1/12 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Psychiatric disorders Libido decreased	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Renal and urinary disorders Incidental finding of renal cell cancer	0.00% 0/25 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	4.2% 1/24 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Skin and subcutaneous tissue disorders Pruritus	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 2/24 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 1/12 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	12.0% 3/25 • Number of events 3 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	20.8% 5/24 • Number of events 5 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Cardiac disorders Myocardial infarction	0.00% 0/25 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 1/12 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Ear and labyrinth disorders Ear pain	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Ear and labyrinth disorders Vertigo	8.0% 2/25 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Gastrointestinal disorders Bloating	8.0% 2/25 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Gastrointestinal disorders Dry mouth	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Gastrointestinal disorders Dysphagia	0.00% 0/25 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	4.2% 1/24 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/25 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 1/12 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Gastrointestinal disorders Gastrointestinal pain	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Gastrointestinal disorders Nausea	24.0% 6/25 • Number of events 6 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	16.7% 4/24 • Number of events 4 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 1/12 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
General disorders Fatigue	12.0% 3/25 • Number of events 3 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
General disorders Fever	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
General disorders Gel flaking	8.0% 2/25 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	20.8% 5/24 • Number of events 5 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	16.7% 2/12 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
General disorders Malaise	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
General disorders Pain	8.0% 2/25 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 2/24 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 1/12 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Infections and infestations Rhinitis infective	0.00% 0/25 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	4.2% 1/24 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Infections and infestations Skin infection	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Infections and infestations Urinary tract infection	0.00% 0/25 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 2/24 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Infections and infestations Vaginal infection	0.00% 0/25 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	4.2% 1/24 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Injury, poisoning and procedural complications Bruising	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	4.2% 1/24 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Injury, poisoning and procedural complications Fall	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Injury, poisoning and procedural complications Seroma	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Investigations Abnormal erythrocyte parameter	4.0% 1/25 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	4.2% 1/24 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Investigations Alanine aminotransferase increased	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Investigations Creatinine increased	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	4.2% 1/24 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Investigations Elevated fibrinogen	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Investigations Low antithrombin 3 level	20.0% 5/25 • Number of events 5 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Investigations Lymphocyte count increased	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Investigations Path upstage	4.0% 1/25 • Number of events 2 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 2/24 • Number of events 3 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	8.3% 1/12 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Investigations Research imaging prompted additional imaging and biopsy	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Investigations White blood cell decreased	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	4.2% 1/24 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Metabolism and nutrition disorders Anorexia	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Metabolism and nutrition disorders Increased thirst	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 1/25 • Number of events 1 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/24 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.	0.00% 0/12 • Adverse Events were collected during the period of intervention (1 month) and for 1 month after end of intervention for a total of 2 months.